EnsoSleep
K-Number: K162627 · 2017-03-31
ApplicantEnsodata, Inc.
Decision Date2017-03-31
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
EnsoSleep is a medical device manufactured by Ensodata, Inc.. It received FDA 510(k) clearance on 2017-03-31 under approval number K162627. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EnsoSleep?
EnsoSleep is a medical device that received FDA 510(k) clearance on 2017-03-31. It is manufactured by Ensodata, Inc.. The 510(k) number is K162627.
When was EnsoSleep approved by the FDA?
EnsoSleep received FDA 510(k) clearance on 2017-03-31, under approval number K162627.
What company makes EnsoSleep?
EnsoSleep is manufactured by Ensodata, Inc..
What is the FDA product code for EnsoSleep?
The FDA product code for EnsoSleep is OLZ.
Other Devices by Ensodata, Inc.
Related Devices (Code: OLZ)
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.