BIOTOME— 510(k) K771711

Substantially Equivalent

Berkeley Bio-Engineering

FDA 510(k) clearance K771711 for BIOTOME, Substantially Equivalent on 1977-09-28. Applicant: Berkeley Bio-Engineering.

Clearance details

Applicant: Berkeley Bio-Engineering
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1977-09-12
Decision date: 1977-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

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.