BIOCHEM 3100 OXIMETER— 510(k) K893877

Substantially Equivalent

Biochem International, Inc.

FDA 510(k) clearance K893877 for BIOCHEM 3100 OXIMETER, Substantially Equivalent on 1989-12-20. Applicant: Biochem International, Inc..

Clearance details

Applicant: Biochem International, Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1989-05-26
Decision date: 1989-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.