Company ยท US
Spacelabs, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1996. Name variants (Inc, Corp, punctuation) are merged.
46510(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 | 11 |
| DQA | Oximeter | 4 |
| DPS | Electrocardiograph | 3 |
| DSH | Recorder, Magnetic Tape, Medical | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 |
| DQK | Computer, Diagnostic, Programmable | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 |
| FLL | Continuous Measurement Thermometer | 2 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 2 |
| LOS | 2 | |
| BZA | Connector, Airway (Extension) | 1 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 |
| DSF | Recorder, Paper Chart | 1 |
| DSK | Computer, Blood-Pressure | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 |
| DXK | Echocardiograph | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 31, 1996 | K954962 | SPACELABS MEDICAL MULTIGAS ANALYZER Spacelabs, Inc. | CBR |
| Jul 14, 1995 | K951605 | SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM Spacelabs, Inc. | DSH |
| Apr 25, 1995 | K950779 | HEART RATE VARIABILITY SOFTWARE OPTION Spacelabs, Inc. | DPS |
| Oct 6, 1994 | K941165 | COMET CAPNOGRAPH MODULE Spacelabs, Inc. | CCK |
| Dec 6, 1993 | K923788 | SPACE LABS MODEL 90560 Spacelabs, Inc. | LOS |
| Apr 20, 1992 | K912742 | ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE Spacelabs, Inc. | FLL |
| Oct 4, 1991 | K913038 | SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION Spacelabs, Inc. | DSH |
| Apr 12, 1991 | K905065 | DEFIBRILLATOR LEAD ADAPTER Spacelabs, Inc. | LDD |
| Jan 31, 1991 | K910029 | PATIENT CARE MANAGEMENT SYSTEM MODIFICATION Spacelabs, Inc. | DXK |
| Dec 27, 1990 | K896903 | FIRST MEDIC MODEL 510 Spacelabs, Inc. | LDD |
| Dec 18, 1990 | K904318 | LOCAL REPORT GENERATOR Spacelabs, Inc. | DXN |
| Oct 19, 1990 | K903702 | MODEL 90421 FLEXPORT INTERFACE Spacelabs, Inc. | DQA |
| Apr 30, 1990 | K901209 | MODEL 90489 PULSE OXIMETER MODULE Spacelabs, Inc. | DQA |
| Mar 8, 1990 | K896942 | SPACELABS MODEL 90480 EEG MODULE Spacelabs, Inc. | GWQ |
| Jan 24, 1990 | K896427 | SPACELABS' MODEL 90514, MULTIGAS ANALYZER Spacelabs, Inc. | CCL |
| Nov 30, 1989 | K894093 | SPACELABS MODEL 90900 Spacelabs, Inc. | LOS |
| Sep 13, 1989 | K893867 | CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE Spacelabs, Inc. | DQA |
| Mar 11, 1987 | K864279 | SPACELABS MODEL 90419 PULSE OXIMETER MODULE Spacelabs, Inc. | DQA |
| Nov 25, 1986 | K864506 | SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1 Spacelabs, Inc. | DSI |
| Nov 24, 1986 | K864505 | SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 Spacelabs, Inc. | DSI |
| Sep 23, 1986 | K862951 | SPACELABS SERIES 90700 PATIENT MONITORS Spacelabs, Inc. | DPS |
| Aug 14, 1986 | K855127 | AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202 Spacelabs, Inc. | DXN |
| Jul 30, 1986 | K860689 | SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE Spacelabs, Inc. | DSK |
| May 21, 1986 | K860980 | PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III Spacelabs, Inc. | DSI |
| Apr 29, 1986 | K860834 | SPACELABS MEDICAL WORKSTATION Spacelabs, Inc. | DSI |
| Mar 19, 1986 | K860352 | SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014 Spacelabs, Inc. | BZA |
| May 28, 1985 | K850627 | SPACELABS-GENERAL SYSTEM LINK Spacelabs, Inc. | DQK |
| Feb 14, 1985 | K844940 | SPACELABS MODEL 90201 HOLTER RECORDER Spacelabs, Inc. | DSH |
| Feb 1, 1985 | K844888 | SPACELABS SERIES 600 PATIENT MONITORS Spacelabs, Inc. | DRT |
| Oct 18, 1984 | K842616 | SPACELABS ALPHA PC PATIENT COMPUTER Spacelabs, Inc. | DSI |
| Oct 4, 1984 | K842640 | SPACELABS ICR ARRHYTHMIA MASTER I HOLTER Spacelabs, Inc. | DSI |
| Aug 24, 1984 | K842978 | 540 CAPNOGRAPH Spacelabs, Inc. | CCK |
| Apr 17, 1984 | K834597 | ALPHA MASS STORAGE CARDULE 1895 Spacelabs, Inc. | DSI |
| Feb 13, 1984 | K834460 | MODEL 1888 ALPHA COS/RESPIRATION CAR Spacelabs, Inc. | LLK |
| Jan 27, 1984 | K832764 | ALPHA NON-INVASIVE BP CARDULE Spacelabs, Inc. | DXN |
| Jan 27, 1984 | K832644 | ALPHA CARDIAC OUTPUT CARDULE #1899 Spacelabs, Inc. | DXG |
| Nov 7, 1983 | K832693 | ARRHYTHMIA III CARDULE #1919 Spacelabs, Inc. | DSI |
| Mar 17, 1983 | K830306 | HEARTRATE PLUS ECG CARDULE #1918 Spacelabs, Inc. | DSI |
| Aug 13, 1981 | K811540 | SPACELABS' SYSTEM AUTORECORDER Spacelabs, Inc. | DSF |
| Oct 2, 1979 | K791776 | ARRHYTHMIA II EDITOR Spacelabs, Inc. | DQK |
| May 16, 1979 | K790837 | ARRHYTHMIA II CARDULE Spacelabs, Inc. | DSI |
| Dec 4, 1978 | K781836 | TELEMETRY SYSTEM, BIOTEL 300 Spacelabs, Inc. | DRG |
| Dec 23, 1976 | K761244 | SERIES 700 PATIENT MONITORS Spacelabs, Inc. | FLL |
| Dec 9, 1976 | K760884 | MICRO-COMPUTER ARRHYTHONIA SYSTEM Spacelabs, Inc. | DSI |
| Sep 21, 1976 | K760612 | SPACELABS SERIES 1000 Spacelabs, Inc. | DPS |
| Jul 20, 1976 | K760120 | PULSE CARDULE (MODEL 1859/1860 ECG) Spacelabs, Inc. | DRT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||