FDA 510(k)

ASSISTO Universal Applicator Clamping Device

Número K: K201279 · 2020-07-10

RequerenteGeomed Medizin-Technik GmbH & Co. KG

Data da decisão2020-07-10

Código do produtoJAQ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ASSISTO Universal Applicator Clamping Device is the device name listed in this FDA 510(k) record. The listed applicant is Geomed Medizin-Technik GmbH & Co. KG. It received FDA 510(k) clearance on 2020-07-10 under 510(k) number K201279. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ASSISTO Universal Applicator Clamping Device?

ASSISTO Universal Applicator Clamping Device is a medical device that received FDA 510(k) clearance on 2020-07-10. The listed applicant is Geomed Medizin-Technik GmbH & Co. KG. The 510(k) number is K201279.

When did ASSISTO Universal Applicator Clamping Device receive FDA 510(k) clearance?

ASSISTO Universal Applicator Clamping Device received FDA 510(k) clearance on 2020-07-10, under 510(k) number K201279.

Who is the listed applicant for ASSISTO Universal Applicator Clamping Device?

The FDA 510(k) record lists Geomed Medizin-Technik GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASSISTO Universal Applicator Clamping Device?

The FDA product code for ASSISTO Universal Applicator Clamping Device is JAQ.

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