FDA 510(k)

THUNDERBEAT Open Fine Jaw

Número K: K151743 · 2016-02-26

Data da decisão2016-02-26

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

THUNDERBEAT Open Fine Jaw is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2016-02-26 under 510(k) number K151743. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the THUNDERBEAT Open Fine Jaw?

THUNDERBEAT Open Fine Jaw is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K151743.

When did THUNDERBEAT Open Fine Jaw receive FDA 510(k) clearance?

THUNDERBEAT Open Fine Jaw received FDA 510(k) clearance on 2016-02-26, under 510(k) number K151743.

Who is the listed applicant for THUNDERBEAT Open Fine Jaw?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THUNDERBEAT Open Fine Jaw?

The FDA product code for THUNDERBEAT Open Fine Jaw is GEI.

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