FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260

K Number: K873149 · Decision Nov 6, 1987
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
45
Review Days
87

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Basic Information

Device Name
NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260
K Number
K873149
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1400
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Novametrix Medical Systems, Inc.
Date Received
August 11, 1987
Decision Date
November 6, 1987
Product Code
CCK
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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Other Clearances by Novametrix Medical Systems, Inc.

K Number Device Name
K010451 NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
K000794 MODIFICATION TO MARSPO2, MODEL 2001
K993979 MARSPO2, MODEL 2001
K982499 COSMO PLUS WITH NICO, MODEL 8200
K964360 VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
K963380 CO 2 SMO PLUS
K963327 TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
K960831 VENTRAK RMMS 1550
K924626 NOVAMETRIX MODEL 510
K920379 NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
Search all 45 clearances from Novametrix Medical Systems, Inc. →