Zmachine Synergy— 510(k) K172986

Name: FDA 510(k) clearance K172986
Creator: U.S. Food and Drug Administration
Published: 2017-12-19

Substantially Equivalent

Consolidated Research of Richmond, Inc. Dba General Sleep CO

FDA 510(k) clearance K172986 for Zmachine Synergy, Substantially Equivalent on 2017-12-19. Applicant: Consolidated Research of Richmond, Inc. Dba General Sleep CO. Device class: 2.

Clearance details

Applicant: Consolidated Research of Richmond, Inc. Dba General Sleep CO
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2017-09-27
Decision date: 2017-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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