FDA 510(k)

REMY Medical Therapy Laser System

Número K: K190034 · 2019-05-15

Data da decisão2019-05-15

Código do produtoPDZ

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

REMY Medical Therapy Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Footdocprenur, LLC. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K190034. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the REMY Medical Therapy Laser System?

REMY Medical Therapy Laser System is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is Footdocprenur, LLC. The 510(k) number is K190034.

When did REMY Medical Therapy Laser System receive FDA 510(k) clearance?

REMY Medical Therapy Laser System received FDA 510(k) clearance on 2019-05-15, under 510(k) number K190034.

Who is the listed applicant for REMY Medical Therapy Laser System?

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

What is the FDA product code for REMY Medical Therapy Laser System?

The FDA product code for REMY Medical Therapy Laser System is PDZ.

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