510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K971084Substantially Equivalent

Model 02 Oxygen Analyzer

Oxigraf, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971084 is the FDA 510(k) clearance record for MODEL 02 OXYGEN ANALYZER, a class II device, cleared for Oxigraf, Inc. on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list one 510(k) clearance for Oxigraf, Inc. As of , FDA records show no recalls naming K971084.

Clearance record

Decision date
Received
(483 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
Oxigraf, Inc. 1170 Terra Bella Ave., Mountain View CA
510(k) summary
Summary
Third party review
No

Clearances, product code CCL

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