FDA 510(k)

BostonSight PD Prosthetic Device

Número K: K161461 · 2016-07-25

Data da decisão2016-07-25

Código do produtoHQD

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

BostonSight PD Prosthetic Device is the device name listed in this FDA 510(k) record. The listed applicant is Bostonsight. It received FDA 510(k) clearance on 2016-07-25 under 510(k) number K161461. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BostonSight PD Prosthetic Device?

BostonSight PD Prosthetic Device is a medical device that received FDA 510(k) clearance on 2016-07-25. The listed applicant is Bostonsight. The 510(k) number is K161461.

When did BostonSight PD Prosthetic Device receive FDA 510(k) clearance?

BostonSight PD Prosthetic Device received FDA 510(k) clearance on 2016-07-25, under 510(k) number K161461.

Who is the listed applicant for BostonSight PD Prosthetic Device?

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

What is the FDA product code for BostonSight PD Prosthetic Device?

The FDA product code for BostonSight PD Prosthetic Device is HQD.

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Outros registros que listam Bostonsight como candidato(a)

K183175BostonSight Scleral

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Fonte oficial

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