FDA 510(k)

TotalShield II Surgical Helmet System

Número K: K192194 · 2019-10-15

Data da decisão2019-10-15

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

TotalShield II Surgical Helmet System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-15 under 510(k) number K192194. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TotalShield II Surgical Helmet System?

TotalShield II Surgical Helmet System is a medical device that received FDA 510(k) clearance on 2019-10-15. The listed applicant is Zimmer Surgical, Inc.. The 510(k) number is K192194.

When did TotalShield II Surgical Helmet System receive FDA 510(k) clearance?

TotalShield II Surgical Helmet System received FDA 510(k) clearance on 2019-10-15, under 510(k) number K192194.

Who is the listed applicant for TotalShield II Surgical Helmet System?

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

What is the FDA product code for TotalShield II Surgical Helmet System?

The FDA product code for TotalShield II Surgical Helmet System is FYA.

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