FDA 510(k)

DESCRIBE PFD Patch

Número K: K172689 · 2017-11-29

Data da decisão2017-11-29

Código do produtoPKO

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DESCRIBE PFD Patch is the device name listed in this FDA 510(k) record. The listed applicant is Merz North America, Inc.. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K172689. The device is classified under product code PKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DESCRIBE PFD Patch?

DESCRIBE PFD Patch is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Merz North America, Inc.. The 510(k) number is K172689.

When did DESCRIBE PFD Patch receive FDA 510(k) clearance?

DESCRIBE PFD Patch received FDA 510(k) clearance on 2017-11-29, under 510(k) number K172689.

Who is the listed applicant for DESCRIBE PFD Patch?

The FDA 510(k) record lists Merz North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DESCRIBE PFD Patch?

The FDA product code for DESCRIBE PFD Patch is PKO.

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