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

AVL MODEL 940 AUTOMATIC PH/BLOOD GAS

K Number: K792230 · Decision Dec 31, 1979
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
187
Applicant Total
2
Review Days
56

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Basic Information

Device Name
AVL MODEL 940 AUTOMATIC PH/BLOOD GAS
K Number
K792230
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
862.1120
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Applicant
Gauntlet Technology Corp.
Date Received
November 5, 1979
Decision Date
December 31, 1979
Product Code
CHL
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
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

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Other Clearances by Gauntlet Technology Corp.

K Number Device Name
K801011 AVL #980 ELECTROLYTE ANALYZER