FDA 510(k)

Zmachine Synergy

Número K: K172986 · 2017-12-19

RequerenteConsolidated Research of Richmond, Inc. Dba General Sleep CO

Data da decisão2017-12-19

Código do produtoOLV

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Zmachine Synergy is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Research of Richmond, Inc. Dba General Sleep CO. It received FDA 510(k) clearance on 2017-12-19 under 510(k) number K172986. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Zmachine Synergy?

Zmachine Synergy is a medical device that received FDA 510(k) clearance on 2017-12-19. The listed applicant is Consolidated Research of Richmond, Inc. Dba General Sleep CO. The 510(k) number is K172986.

When did Zmachine Synergy receive FDA 510(k) clearance?

Zmachine Synergy received FDA 510(k) clearance on 2017-12-19, under 510(k) number K172986.

Who is the listed applicant for Zmachine Synergy?

The FDA 510(k) record lists Consolidated Research of Richmond, Inc. Dba General Sleep CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zmachine Synergy?

The FDA product code for Zmachine Synergy is OLV.

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