FDA 510(k)

TD Clip

Número K: K190051 · 2019-06-07

RequerenteZephyr Sleep Technologies, Inc.

Data da decisão2019-06-07

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TD Clip is the device name listed in this FDA 510(k) record. The listed applicant is Zephyr Sleep Technologies, Inc.. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K190051. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TD Clip?

TD Clip is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Zephyr Sleep Technologies, Inc.. The 510(k) number is K190051.

When did TD Clip receive FDA 510(k) clearance?

TD Clip received FDA 510(k) clearance on 2019-06-07, under 510(k) number K190051.

Who is the listed applicant for TD Clip?

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

What is the FDA product code for TD Clip?

The FDA product code for TD Clip is LRK.

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Fonte oficial

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