HYPERLITE— 510(k) K905168

Substantially Equivalent

S.O.S. , Ltd.

FDA 510(k) clearance K905168 for HYPERLITE, Substantially Equivalent on 1991-07-22. Applicant: S.O.S. , Ltd..

Clearance details

Applicant: S.O.S. , Ltd.
Product code: Code CBF
Advisory panel: Anesthesiology
Date received: 1990-11-16
Decision date: 1991-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London Nw73js, England, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBF

product code CBF

Death: 6
Total: 6

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.