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FDA 510(k)

OtoSet- Ear Cleaning System

Número K: K201877 · 2020-11-05

RequerenteSafkan, Inc.
Data da decisão2020-11-05
Código do produtoKYZ
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

OtoSet- Ear Cleaning System is the device name listed in this FDA 510(k) record. The listed applicant is Safkan, Inc.. It received FDA 510(k) clearance on 2020-11-05 under 510(k) number K201877. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OtoSet- Ear Cleaning System?

OtoSet- Ear Cleaning System is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Safkan, Inc.. The 510(k) number is K201877.

When did OtoSet- Ear Cleaning System receive FDA 510(k) clearance?

OtoSet- Ear Cleaning System received FDA 510(k) clearance on 2020-11-05, under 510(k) number K201877.

Who is the listed applicant for OtoSet- Ear Cleaning System?

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

What is the FDA product code for OtoSet- Ear Cleaning System?

The FDA product code for OtoSet- Ear Cleaning System is KYZ.

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Fonte oficial

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