FDA 510(k)

MicrO2 OSA Device with Micro-Recorder

Número K: K161624 · 2016-11-07

Data da decisão2016-11-07

Código do produtoPLC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

MicrO2 OSA Device with Micro-Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Microdental, Inc.. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K161624. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MicrO2 OSA Device with Micro-Recorder?

MicrO2 OSA Device with Micro-Recorder is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is Microdental, Inc.. The 510(k) number is K161624.

When did MicrO2 OSA Device with Micro-Recorder receive FDA 510(k) clearance?

MicrO2 OSA Device with Micro-Recorder received FDA 510(k) clearance on 2016-11-07, under 510(k) number K161624.

Who is the listed applicant for MicrO2 OSA Device with Micro-Recorder?

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

What is the FDA product code for MicrO2 OSA Device with Micro-Recorder?

The FDA product code for MicrO2 OSA Device with Micro-Recorder is PLC.

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Fonte oficial

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