Company ยท US
Hewlett-Packard Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2000. Name variants (Inc, Corp, punctuation) are merged.
246510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 22 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 20 |
| DPS | Electrocardiograph | 15 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 14 |
| HGM | System, Monitoring, Perinatal | 13 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 10 |
| DQA | Oximeter | 8 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 8 |
| DXJ | Display, Cathode-Ray Tube, Medical | 7 |
| ITX | Transducer, Ultrasonic, Diagnostic | 7 |
| LOS | 7 | |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 6 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 6 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 6 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 6 |
| DQK | Computer, Diagnostic, Programmable | 5 |
| DRR | Amplifier And Signal Conditioner, Biopotential | 5 |
| DRS | Transducer, Blood-Pressure, Extravascular | 5 |
| DRX | Electrode, Electrocardiograph | 5 |
| DSF | Recorder, Paper Chart | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 2000 | K992543 | HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE Hewlett-Packard Co. | MKJ |
| Feb 3, 2000 | K993383 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B Hewlett-Packard GmbH, DE | DSI |
| Jan 28, 2000 | K992273 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B Hewlett-Packard GmbH, DE | MHX |
| Jan 20, 2000 | K993587 | HP M2376A DEVICE LINK SYSTEM Hewlett-Packard Co. | MQS |
| Dec 20, 1999 | K993169 | MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A Hewlett-Packard Co. | DRG |
| Dec 8, 1999 | K992595 | HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH Hewlett-Packard GmbH, DE | MHX |
| Dec 1, 1999 | K992977 | HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A Hewlett-Packard Co. | MKJ |
| Nov 8, 1999 | K993516 | HP M2600A VIRIDIA TELEMETRY SYSTEM Hewlett-Packard Co. | DSI |
| Nov 8, 1999 | K992674 | HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A Hewlett-Packard GmbH, DE | MHX |
| Oct 21, 1999 | K993171 | HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A Hewlett-Packard Co. | DSI |
| Aug 31, 1999 | K992636 | HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A Hewlett-Packard Co. | DXJ |
| Aug 5, 1999 | K991871 | HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A Hewlett-Packard Co. | MKJ |
| Jul 22, 1999 | K990476 | HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION Hewlett-Packard GmbH, DE | MHX |
| Jun 7, 1999 | K991773 | HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P Hewlett-Packard GmbH, DE | DSI |
| Apr 30, 1999 | K984194 | HP M2376A DEVICE LINK SYSTEM Hewlett-Packard Co. | MQS |
| Apr 19, 1999 | K990972 | HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T Hewlett-Packard GmbH, DE | DSI |
| Feb 24, 1999 | K990400 | LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. | ITX |
| Feb 18, 1999 | K990339 | SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O Hewlett-Packard Co. | IYN |
| Jan 29, 1999 | K990125 | HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K Hewlett-Packard GmbH, DE | DSI |
| Jan 4, 1999 | K981376 | HEWLETT-PACKARD M1205A VIRIDIA 24 CT Hewlett-Packard Co. | DSI |
| Dec 17, 1998 | K984286 | HEARTSTREAM ELECTRODE ADAPTER Hewlett-Packard Co. | MKJ |
| Sep 9, 1998 | K980429 | HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM) Hewlett-Packard Co. | DSI |
| Sep 4, 1998 | K982025 | HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR Hewlett-Packard Co. | MKJ |
| Aug 12, 1998 | K982619 | HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02 Hewlett-Packard Co. | CCL |
| Jul 17, 1998 | K981576 | MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A Hewlett-Packard GmbH, DE | MHX |
| Jul 14, 1998 | K974457 | SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T Hewlett-Packard Co. | IYO |
| Jun 23, 1998 | K981265 | PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA Hewlett-Packard Co. | LOS |
| Jun 15, 1998 | K974087 | MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT Hewlett-Packard Co. | LOS |
| May 22, 1998 | K980687 | SONOS 5500 ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. | IYO |
| Mar 23, 1998 | K971910 | MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A) Hewlett-Packard GmbH, DE | DSI |
| Mar 18, 1998 | K974746 | M1765A ECG MANAGER Hewlett-Packard Co. | DPS |
| Feb 19, 1998 | K974420 | M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION Hewlett-Packard Co. | DSH |
| Jan 20, 1998 | K974567 | HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER Hewlett-Packard Co. | MSX |
| Jan 12, 1998 | K971116 | SONOS 5500 IMAGING SYSTEM Hewlett-Packard Co. | ITX |
| Dec 3, 1997 | K973437 | HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES Hewlett-Packard GmbH, DE | DPS |
| Oct 3, 1997 | K970456 | HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM Hewlett-Packard GmbH, DE | HGM |
| Sep 11, 1997 | K965160 | HP ORVUE INTRA-OP (M2510A) Hewlett-Packard GmbH, DE | BSZ |
| Jul 24, 1997 | K972348 | HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM Hewlett-Packard Co. | ITX |
| May 15, 1997 | K964832 | HEWLETT-PACKARD CENTRALVUE SOFTWARE Hewlett-Packard Co. | DSI |
| Apr 22, 1997 | K964309 | SONOS 2000, SONOS 2500 (M2406 A) Hewlett-Packard Co. | IYN |
| Mar 19, 1997 | K963706 | PHILIPS SONO DIAGNOST 800 Hewlett-Packard Co. | IYO |
| Mar 17, 1997 | K970034 | SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. | ITX |
| Jan 8, 1997 | K964122 | HP STAR ST AND ARRHHYTHMIA SOFTWARE Hewlett-Packard Co. | DSI |
| Oct 10, 1996 | K961165 | HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A Hewlett-Packard Co. | DSI |
| Oct 8, 1996 | K961401 | HP CATHSTATION - MODEL M1264B Hewlett-Packard Co. | DPS |
| Aug 8, 1996 | K954028 | HP SONOS ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. | IYN |
| Jun 17, 1996 | K961009 | STRESSWRITER EXERCISE TESTING SYSTEM Hewlett-Packard Co. | DQK |
| Jun 14, 1996 | K960934 | HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 Hewlett-Packard Co. | MLD |
| May 15, 1996 | K954980 | PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO Hewlett-Packard Co. | LOS |
| May 7, 1996 | K954957 | CODEMASTER XL + XL W/SHOCK ADVISORY OPTION Hewlett-Packard Co. | MKJ |
Newest 50 of 246.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||