FDA 510(k)

CUR Model 1

Número K: K160052 · 2016-05-20

Data da decisão2016-05-20

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

CUR Model 1 is the device name listed in this FDA 510(k) record. The listed applicant is Thimble Bioelectronics, Inc.. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K160052. 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 CUR Model 1?

CUR Model 1 is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Thimble Bioelectronics, Inc.. The 510(k) number is K160052.

When did CUR Model 1 receive FDA 510(k) clearance?

CUR Model 1 received FDA 510(k) clearance on 2016-05-20, under 510(k) number K160052.

Who is the listed applicant for CUR Model 1?

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

What is the FDA product code for CUR Model 1?

The FDA product code for CUR Model 1 is NUH.

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