FDA 510(k)

Sheathes Ultrasound Probe Covers

Número K: K153212 · 2016-03-04

Data da decisão2016-03-04

Código do produtoITX

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sheathes Ultrasound Probe Covers is the device name listed in this FDA 510(k) record. The listed applicant is Sheathing Technologies, Inc.. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K153212. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sheathes Ultrasound Probe Covers?

Sheathes Ultrasound Probe Covers is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Sheathing Technologies, Inc.. The 510(k) number is K153212.

When did Sheathes Ultrasound Probe Covers receive FDA 510(k) clearance?

Sheathes Ultrasound Probe Covers received FDA 510(k) clearance on 2016-03-04, under 510(k) number K153212.

Who is the listed applicant for Sheathes Ultrasound Probe Covers?

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

What is the FDA product code for Sheathes Ultrasound Probe Covers?

The FDA product code for Sheathes Ultrasound Probe Covers is ITX.

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