FDA 510(k)

ELAN 4 Tools

Número K: K182527 · 2019-01-19

Data da decisão2019-01-19

Código do produtoHBE

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ELAN 4 Tools is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2019-01-19 under 510(k) number K182527. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ELAN 4 Tools?

ELAN 4 Tools is a medical device that received FDA 510(k) clearance on 2019-01-19. The listed applicant is Aesculap, Inc.. The 510(k) number is K182527.

When did ELAN 4 Tools receive FDA 510(k) clearance?

ELAN 4 Tools received FDA 510(k) clearance on 2019-01-19, under 510(k) number K182527.

Who is the listed applicant for ELAN 4 Tools?

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

What is the FDA product code for ELAN 4 Tools?

The FDA product code for ELAN 4 Tools is HBE.

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Fonte oficial

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