BIO FLOTE(R)— 510(k) K900131

Substantially Equivalent

Bio Clinic Co.

FDA 510(k) clearance K900131 for BIO FLOTE(R), Substantially Equivalent on 1990-02-16. Applicant: Bio Clinic Co..

Clearance details

Applicant: Bio Clinic Co.
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1990-01-10
Decision date: 1990-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Cucamonga, CA, US

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Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.