Company ยท US
Novametrix Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2001. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 13 |
| DQA | Oximeter | 8 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 5 |
| BZC | Calculator, Pulmonary Function Data | 4 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 4 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 |
| DSF | Recorder, Paper Chart | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 1 |
| LKD | Monitor, Carbon-Dioxide, Cutaneous | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 25, 2001 | K010451 | NOVAMETRIX MARQUETTE COMPATIBLE SENSORS Novametrix Medical Systems, Inc. | DQA |
| Apr 10, 2000 | K000794 | MODIFICATION TO MARSPO2, MODEL 2001 Novametrix Medical Systems, Inc. | DQA |
| Feb 22, 2000 | K993979 | MARSPO2, MODEL 2001 Novametrix Medical Systems, Inc. | DQA |
| Oct 16, 1998 | K982499 | COSMO PLUS WITH NICO, MODEL 8200 Novametrix Medical Systems, Inc. | BZC |
| Apr 4, 1997 | K964360 | VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 Novametrix Medical Systems, Inc. | BZC |
| Jan 22, 1997 | K963380 | CO 2 SMO PLUS Novametrix Medical Systems, Inc. | BZC |
| Nov 20, 1996 | K963327 | TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 Novametrix Medical Systems, Inc. | CCK |
| May 29, 1996 | K960831 | VENTRAK RMMS 1550 Novametrix Medical Systems, Inc. | BZC |
| Dec 3, 1993 | K924626 | NOVAMETRIX MODEL 510 Novametrix Medical Systems, Inc. | DQA |
| Jul 15, 1992 | K920379 | NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX Novametrix Medical Systems, Inc. | DQA |
| Nov 4, 1991 | K913516 | MODEL 520A NOVAMETRIX PULSE OXIMETER Novametrix Medical Systems, Inc. | DQA |
| Mar 26, 1991 | K910019 | NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON Novametrix Medical Systems, Inc. | CCK |
| Oct 26, 1989 | K893643 | NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER Novametrix Medical Systems, Inc. | DQA |
| Apr 14, 1989 | K890517 | TRANSCUTANEOUS O2/CO2 MONITOR Novametrix Medical Systems, Inc. | LKD |
| Dec 3, 1987 | K873672 | MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR Novametrix Medical Systems, Inc. | DRG |
| Nov 6, 1987 | K874036 | MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY Novametrix Medical Systems, Inc. | CCK |
| Nov 6, 1987 | K873149 | NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260 Novametrix Medical Systems, Inc. | CCK |
| Sep 23, 1987 | K873078 | NOVAMETRIX MODEL 505 PULSE OXIMETER Novametrix Medical Systems, Inc. | DQA |
| Aug 4, 1987 | K871338 | NOVAMETRIX MODEL 200 MAGSTIM Novametrix Medical Systems, Inc. | GWF |
| May 27, 1987 | K870805 | MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR Novametrix Medical Systems, Inc. | KLK |
| Nov 6, 1985 | K853124 | NOVAMETRIX PULSE OXIMETER, MODEL 500 Novametrix Medical Systems, Inc. | JOM |
| Mar 29, 1985 | K850487 | NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER Novametrix Medical Systems, Inc. | DSF |
| Feb 21, 1985 | K844010 | CPNOGARD CAPNOMETER 1250 Novametrix Medical Systems, Inc. | CCK |
| Jan 10, 1985 | K844253 | NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 Novametrix Medical Systems, Inc. | KLK |
| Nov 30, 1984 | K844079 | NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN Novametrix Medical Systems, Inc. | KLK |
| Sep 17, 1984 | K842374 | NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN Novametrix Medical Systems, Inc. | KLK |
| Apr 24, 1984 | K840993 | TRANSCUTANEOUS 800-OXYGEN MONITORS/801 Novametrix Medical Systems, Inc. | KLK |
| Apr 17, 1984 | K840560 | NEONATAL PHYSIOLOGICAL MONITOR 903 Novametrix Medical Systems, Inc. | DRT |
| Feb 27, 1984 | K840392 | NOVOX OXYGEN ANALYZER 400 Novametrix Medical Systems, Inc. | CCL |
| Aug 12, 1983 | K831578 | PHYSIOLOGICAL MONITOR #902 Novametrix Medical Systems, Inc. | DRT |
| Jun 25, 1982 | K821720 | PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000 Novametrix Medical Systems, Inc. | DRT |
| Feb 12, 1982 | K813350 | NOVAMETRIX MODEL 807 TRANSCUT. MONITOR Novametrix Medical Systems, Inc. | KLK |
| Jan 7, 1982 | K813352 | NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN Novametrix Medical Systems, Inc. | KLK |
| Dec 31, 1981 | K813351 | NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER Novametrix Medical Systems, Inc. | KLK |
| Sep 8, 1981 | K811893 | NOVAMETRIX PHYSIOLOGICAL MONITOR #910 Novametrix Medical Systems, Inc. | DRT |
| Jul 10, 1981 | K811453 | NOVATRACER RECORDER Novametrix Medical Systems, Inc. | DSF |
| Dec 19, 1980 | K802955 | MONITOR, AIRWAY PRESSURE Novametrix Medical Systems, Inc. | CAP |
| May 28, 1980 | K800988 | NOVAMETRIX TCOMETTE #809 TRANS. MONITOR Novametrix Medical Systems, Inc. | KLK |
| Jan 24, 1980 | K792722 | NOVAMETRIX CPAP NASAL CANNULA Novametrix Medical Systems, Inc. | BZD |
| Nov 16, 1979 | K792011 | TC02M PRECISION GAS CALIBRATOR Novametrix Medical Systems, Inc. | KLK |
| Oct 26, 1979 | K792010 | TC02M ELECTRODE ADHESIVE RINGS Novametrix Medical Systems, Inc. | KLK |
| Oct 26, 1979 | K792009 | TC02 M OXYGEN ELECTRODE CONTACT Novametrix Medical Systems, Inc. | KLK |
| Aug 3, 1979 | K791152 | TCO2M MODEL 818 Novametrix Medical Systems, Inc. | KLK |
| Dec 12, 1978 | K781713 | ADAPTER, C/D SUCTION Novametrix Medical Systems, Inc. | BTR |
| Nov 27, 1978 | K781714 | PNEUMOGARD MODEL 1230 Novametrix Medical Systems, Inc. | CAP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||