FDA 510(k)

PIP Fix

Número K: K181192 · 2018-10-22

Data da decisão2018-10-22

Código do produtoJEC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PIP Fix is the device name listed in this FDA 510(k) record. The listed applicant is Hand Biomechanics Lab, Inc.. It received FDA 510(k) clearance on 2018-10-22 under 510(k) number K181192. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PIP Fix?

PIP Fix is a medical device that received FDA 510(k) clearance on 2018-10-22. The listed applicant is Hand Biomechanics Lab, Inc.. The 510(k) number is K181192.

When did PIP Fix receive FDA 510(k) clearance?

PIP Fix received FDA 510(k) clearance on 2018-10-22, under 510(k) number K181192.

Who is the listed applicant for PIP Fix?

The FDA 510(k) record lists Hand Biomechanics Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIP Fix?

The FDA product code for PIP Fix is JEC.

Outros registros que listam Hand Biomechanics Lab, Inc. como candidato(a)

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Fonte oficial

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