FDA 510(k)

External Remote Controller ERC 4P

Número K: K202348 · 2020-12-22

RequerenteNuvasive Specialized Orthopedics, Inc.

Data da decisão2020-12-22

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

External Remote Controller ERC 4P is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K202348. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the External Remote Controller ERC 4P?

External Remote Controller ERC 4P is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K202348.

When did External Remote Controller ERC 4P receive FDA 510(k) clearance?

External Remote Controller ERC 4P received FDA 510(k) clearance on 2020-12-22, under 510(k) number K202348.

Who is the listed applicant for External Remote Controller ERC 4P?

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

What is the FDA product code for External Remote Controller ERC 4P?

The FDA product code for External Remote Controller ERC 4P is HSB.

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Fonte oficial

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