FDA 510(k)

AED Sinuscope

Número K: K170285 · 2017-08-01

RequerenteNational Advanced Endoscopy Devices, Inc.

Data da decisão2017-08-01

Código do produtoEOB

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

AED Sinuscope is the device name listed in this FDA 510(k) record. The listed applicant is National Advanced Endoscopy Devices, Inc.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K170285. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AED Sinuscope?

AED Sinuscope is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is National Advanced Endoscopy Devices, Inc.. The 510(k) number is K170285.

When did AED Sinuscope receive FDA 510(k) clearance?

AED Sinuscope received FDA 510(k) clearance on 2017-08-01, under 510(k) number K170285.

Who is the listed applicant for AED Sinuscope?

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

What is the FDA product code for AED Sinuscope?

The FDA product code for AED Sinuscope is EOB.

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