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-NumberDeviceDate
K010451NOVAMETRIX MARQUETTE COMPATIBLE SENSORSApril 25, 2001
K000794MODIFICATION TO MARSPO2, MODEL 2001April 10, 2000
K993979MARSPO2, MODEL 2001February 22, 2000
K982499COSMO PLUS WITH NICO, MODEL 8200October 16, 1998
K964360VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101April 4, 1997
K963380CO 2 SMO PLUSJanuary 22, 1997
K963327TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610November 20, 1996
K960831VENTRAK RMMS 1550May 29, 1996
K924626NOVAMETRIX MODEL 510December 3, 1993
K920379NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OXJuly 15, 1992
K913516MODEL 520A NOVAMETRIX PULSE OXIMETERNovember 4, 1991
K910019NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MONMarch 26, 1991
K893643NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETEROctober 26, 1989
K890517TRANSCUTANEOUS O2/CO2 MONITORApril 14, 1989
K873672MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITORDecember 3, 1987
K874036MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRYNovember 6, 1987
K873149NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260November 6, 1987
K873078NOVAMETRIX MODEL 505 PULSE OXIMETERSeptember 23, 1987
K871338NOVAMETRIX MODEL 200 MAGSTIMAugust 4, 1987
K870805MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITORMay 27, 1987