FDA 510(k)

CENTURION Vision System (Active SentryTM)

Número K: K161794 · 2017-04-14

Data da decisão2017-04-14

Código do produtoHQC

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

CENTURION Vision System (Active SentryTM) is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Research, Ltd.. It received FDA 510(k) clearance on 2017-04-14 under 510(k) number K161794. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CENTURION Vision System (Active SentryTM)?

CENTURION Vision System (Active SentryTM) is a medical device that received FDA 510(k) clearance on 2017-04-14. The listed applicant is Alcon Research, Ltd.. The 510(k) number is K161794.

When did CENTURION Vision System (Active SentryTM) receive FDA 510(k) clearance?

CENTURION Vision System (Active SentryTM) received FDA 510(k) clearance on 2017-04-14, under 510(k) number K161794.

Who is the listed applicant for CENTURION Vision System (Active SentryTM)?

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

What is the FDA product code for CENTURION Vision System (Active SentryTM)?

The FDA product code for CENTURION Vision System (Active SentryTM) is HQC.

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