Novametrix Medical Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 45
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K010451 | NOVAMETRIX MARQUETTE COMPATIBLE SENSORS | April 25, 2001 |
| K000794 | MODIFICATION TO MARSPO2, MODEL 2001 | April 10, 2000 |
| K993979 | MARSPO2, MODEL 2001 | February 22, 2000 |
| K982499 | COSMO PLUS WITH NICO, MODEL 8200 | October 16, 1998 |
| K964360 | VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 | April 4, 1997 |
| K963380 | CO 2 SMO PLUS | January 22, 1997 |
| K963327 | TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 | November 20, 1996 |
| K960831 | VENTRAK RMMS 1550 | May 29, 1996 |
| K924626 | NOVAMETRIX MODEL 510 | December 3, 1993 |
| K920379 | NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX | July 15, 1992 |
| K913516 | MODEL 520A NOVAMETRIX PULSE OXIMETER | November 4, 1991 |
| K910019 | NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON | March 26, 1991 |
| K893643 | NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER | October 26, 1989 |
| K890517 | TRANSCUTANEOUS O2/CO2 MONITOR | April 14, 1989 |
| K873672 | MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR | December 3, 1987 |
| K874036 | MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY | November 6, 1987 |
| K873149 | NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260 | November 6, 1987 |
| K873078 | NOVAMETRIX MODEL 505 PULSE OXIMETER | September 23, 1987 |
| K871338 | NOVAMETRIX MODEL 200 MAGSTIM | August 4, 1987 |
| K870805 | MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR | May 27, 1987 |