FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

MARQUEST QC-IV TONOMETER

K Number: K855024 · Decision Apr 7, 1986
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
66
Applicant Total
32
Review Days
111

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Basic Information

Device Name
MARQUEST QC-IV TONOMETER
K Number
K855024
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.1660
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Applicant
Marquest Medical Products, Inc.
Date Received
December 17, 1985
Decision Date
April 7, 1986
Product Code
JJS
Advisory Committee
Clinical Chemistry
Review Advisory Committee
CH
Third Party
N

Classifications

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

Product Code Device Name
JJS Controls For Blood-Gases, (Assayed And Unassayed)

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Other Clearances by Marquest Medical Products, Inc.

K Number Device Name
K050066 C-CO2 COLORIMETRIC CO2 INDICATOR
K970478 SCT 3000 HEATED HUMIDIFIER
K962220 HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
K962223 WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
K960972 DISPOSABLE GAS SAMPLING INTERFACE KITS
K961838 RESPIRGARD II, SPIROGARD
K904690 TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM
K903138 MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM
K902632 GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS
K903307 TEMP MARQ TEMPERATURE TREND INDICATOR
Search all 32 clearances from Marquest Medical Products, Inc. →