FDA 510(k)

MSLS6QF TENS/PMS Device

Número K: K193655 · 2020-09-04

Data da decisão2020-09-04

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

MSLS6QF TENS/PMS Device is the device name listed in this FDA 510(k) record. The listed applicant is Self Doctor Care, LLC. It received FDA 510(k) clearance on 2020-09-04 under 510(k) number K193655. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MSLS6QF TENS/PMS Device?

MSLS6QF TENS/PMS Device is a medical device that received FDA 510(k) clearance on 2020-09-04. The listed applicant is Self Doctor Care, LLC. The 510(k) number is K193655.

When did MSLS6QF TENS/PMS Device receive FDA 510(k) clearance?

MSLS6QF TENS/PMS Device received FDA 510(k) clearance on 2020-09-04, under 510(k) number K193655.

Who is the listed applicant for MSLS6QF TENS/PMS Device?

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

What is the FDA product code for MSLS6QF TENS/PMS Device?

The FDA product code for MSLS6QF TENS/PMS Device is NUH.

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