BIOCHEM MODEL 3301 NEWOX1 OXIMETER— 510(k) K920082

Substantially Equivalent

Biochem International, Inc.

FDA 510(k) clearance K920082 for BIOCHEM MODEL 3301 NEWOX1 OXIMETER, Substantially Equivalent on 1993-01-07. Applicant: Biochem International, Inc..

Clearance details

Applicant: Biochem International, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1992-01-07
Decision date: 1993-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.