Company ยท US
Sensor Medics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2004. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 7 |
| BZG | Spirometer, Diagnostic | 5 |
| DQA | Oximeter | 3 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 2 |
| BZC | Calculator, Pulmonary Function Data | 2 |
| CBP | Valve, Non-Rebreathing | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 1 |
| OLV | Standard Polysomnograph With Electroencephalograph | 1 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 2004 | K032516 | HIOX80 AEROSOL ADAPTER Sensor Medics Corp. | CAF |
| Feb 13, 2004 | K031745 | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION Sensor Medics Corp. | BZD |
| Aug 25, 2003 | K031883 | LYRA NASAL MASK Sensor Medics Corp. | BZD |
| Apr 22, 2003 | K030943 | MODIFICATION TO HIOX Sensor Medics Corp. | CBP |
| Jan 24, 2003 | K022192 | PEGASUS NASAL CPAP SYSTEM Sensor Medics Corp. | BZD |
| Jul 30, 2002 | K020665 | HI-OX Sensor Medics Corp. | CBP |
| Aug 2, 2001 | K012085 | SOMNO STAR & SERIES SLEEP SYSTEM Sensor Medics Corp. | OLV |
| Jul 24, 2001 | K012034 | MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT Sensor Medics Corp. | BZD |
| Aug 13, 1999 | K991972 | INFANT FLOW SYSTEM Sensor Medics Corp. | BZD |
| Feb 24, 1999 | K984254 | INFANT FLOW NCPAP MASKS Sensor Medics Corp. | BZD |
| Oct 30, 1998 | K981366 | STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES Sensor Medics Corp. | BTY |
| Jan 30, 1998 | K974303 | INFANT FLOW SYSTEM Sensor Medics Corp. | BZD |
| Nov 22, 1994 | K942211 | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS Sensor Medics Corp. | BTY |
| Nov 24, 1993 | K934272 | SENSORMEDICS MICROGARD MICROBIAL FILTER Sensor Medics Corp. | CAH |
| Oct 21, 1993 | K923988 | SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS Sensor Medics Corp. | BZG |
| Aug 9, 1993 | K923989 | SENSORMEDICS MODEL 6200 AUTOBOX DL Sensor Medics Corp. | BZG |
| Feb 17, 1993 | K925542 | OXYSHUTTLE II ,MODIFICATION Sensor Medics Corp. | DQA |
| Dec 2, 1992 | K915833 | SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART Sensor Medics Corp. | BZC |
| Dec 1, 1992 | K915686 | MODEL 2900 METABOLIC MEASUREMENT CART Sensor Medics Corp. | BZC |
| Oct 28, 1992 | K915848 | SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. Sensor Medics Corp. | DZJ |
| Oct 26, 1992 | K920111 | SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM Sensor Medics Corp. | BZG |
| Oct 26, 1992 | K915856 | SENSORMEDICS 4000 SERIES SLEEP SYSTEM Sensor Medics Corp. | OLZ |
| Apr 8, 1992 | K920246 | SENSORMEDICS MODEL 922 SPIROMETER Sensor Medics Corp. | BZG |
| Feb 26, 1992 | K913790 | SENSORMEDICS OXYSHUTTLE II(TM) Sensor Medics Corp. | DQA |
| Sep 26, 1986 | K862617 | SENSORMEDICS OXYSHUTTLE(TM) Sensor Medics Corp. | DQA |
| Jun 15, 1984 | K842041 | PULMONARY FUNCTION SYSTEM Sensor Medics Corp. | BZG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||