Zmachine Synergy
K-Number: K172986 · 2017-12-19
Decision Date2017-12-19
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Zmachine Synergy is a medical device manufactured by Consolidated Research of Richmond, Inc. Dba General Sleep CO. It received FDA 510(k) clearance on 2017-12-19 under approval number K172986. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Zmachine Synergy?
Zmachine Synergy is a medical device that received FDA 510(k) clearance on 2017-12-19. It is manufactured by Consolidated Research of Richmond, Inc. Dba General Sleep CO. The 510(k) number is K172986.
When was Zmachine Synergy approved by the FDA?
Zmachine Synergy received FDA 510(k) clearance on 2017-12-19, under approval number K172986.
What company makes Zmachine Synergy?
Zmachine Synergy is manufactured by Consolidated Research of Richmond, Inc. Dba General Sleep CO.
What is the FDA product code for Zmachine Synergy?
The FDA product code for Zmachine Synergy is OLV.
Related Devices (Code: OLV)
K172711Comet-PLUSNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K161650Polysmith Sleep System, Model NTI7593Neurotronics, Inc.
K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNeurotronics, Inc.
K173868Serenity Body Position Sensor, Serenity RIP SensorsNeurotronics, Inc.
K173690Grass TWinNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
K201054SOMNOscreen plusSomnomedics GmbH
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.