510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082655Substantially Equivalent

Envitec Medical Oxygen Senors, Models Oom101; 00M102/-1;Oom103/-1/-1M;oom104;oom105;00m106

Envitec-Wismar GmbH, Egale WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082655 is the FDA 510(k) clearance record for ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106, a class II device, cleared for Envitec-Wismar GmbH on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list 9 510(k) clearances for Envitec-Wismar GmbH, from to . As of , FDA records show no recalls naming K082655.

Clearance record

Decision date
Received
(74 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
Envitec-Wismar GmbH S65w35739 Piper Rd., Egale WI
510(k) summary
Summary PDF
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