BIO-TEK PERCENT OXYGEN MONITOR 74222— 510(k) K831522

Substantially Equivalent

Bio-Tek Instruments, Inc.

FDA 510(k) clearance K831522 for BIO-TEK PERCENT OXYGEN MONITOR 74222, Substantially Equivalent on 1983-09-12. Applicant: Bio-Tek Instruments, Inc..

Clearance details

Applicant: Bio-Tek Instruments, Inc.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 1983-05-12
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.