510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993789Substantially Equivalent

Clinical Blood Gas Mixture

General Air Service and Supply, Commerce City CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993789 is the FDA 510(k) clearance record for CLINICAL BLOOD GAS MIXTURE, a class II device, cleared for General Air Service and Supply on under FDA product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph). FDA records list one 510(k) clearance for General Air Service and Supply. As of , FDA records show no recalls naming K993789.

Clearance record

Decision date
Received
(62 days to decision)
Product code
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Regulation
21 CFR 862.1120
Device class
Class II
Review panel
Clinical Chemistry
Applicant
General Air Service and Supply 6330 Colorado Blvd., Commerce City CO
510(k) summary
Statement
Third party review
No

Clearances, product code CHL

Trailing 12 months
1 clearance under product code CHL in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CHL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260