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FDA 510(k)

HYPERLITE

K-Number: K905168 · 1991-07-22

ApplicantS.O.S. , Ltd.
Decision Date1991-07-22
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HYPERLITE is the device name listed in this FDA 510(k) record. The listed applicant is S.O.S. , Ltd.. It received FDA 510(k) clearance on 1991-07-22 under 510(k) number K905168. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPERLITE?

HYPERLITE is a medical device that received FDA 510(k) clearance on 1991-07-22. The listed applicant is S.O.S. , Ltd.. The 510(k) number is K905168.

When did HYPERLITE receive FDA 510(k) clearance?

HYPERLITE received FDA 510(k) clearance on 1991-07-22, under 510(k) number K905168.

Who is the listed applicant for HYPERLITE?

The FDA 510(k) record lists S.O.S. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPERLITE?

The FDA product code for HYPERLITE is CBF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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