FDA 510(k)

B R A H M S PCT sensitive KRYPTOR

Número K: K171338 · 2017-05-31

Data da decisão2017-05-31

Código do produtoPRI

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

B R A H M S PCT sensitive KRYPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Brahms GmbH. It received FDA 510(k) clearance on 2017-05-31 under 510(k) number K171338. The device is classified under product code PRI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the B R A H M S PCT sensitive KRYPTOR?

B R A H M S PCT sensitive KRYPTOR is a medical device that received FDA 510(k) clearance on 2017-05-31. The listed applicant is Brahms GmbH. The 510(k) number is K171338.

When did B R A H M S PCT sensitive KRYPTOR receive FDA 510(k) clearance?

B R A H M S PCT sensitive KRYPTOR received FDA 510(k) clearance on 2017-05-31, under 510(k) number K171338.

Who is the listed applicant for B R A H M S PCT sensitive KRYPTOR?

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

What is the FDA product code for B R A H M S PCT sensitive KRYPTOR?

The FDA product code for B R A H M S PCT sensitive KRYPTOR is PRI.

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