BIOCHEM TEMPERATURE/ FIO2 MODULE— 510(k) K910381

Substantially Equivalent

Biochem International, Inc.

FDA 510(k) clearance K910381 for BIOCHEM TEMPERATURE/ FIO2 MODULE, Substantially Equivalent on 1991-08-22. Applicant: Biochem International, Inc..

Clearance details

Applicant: Biochem International, Inc.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 1991-01-29
Decision date: 1991-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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Adverse events under product code CCL

product code CCL

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.