EnsoSleep— 510(k) K162627

Substantially Equivalent

Ensodata, Inc.

FDA 510(k) clearance K162627 for EnsoSleep, Substantially Equivalent on 2017-03-31. Applicant: Ensodata, Inc..

Clearance details

Applicant: Ensodata, Inc.
Product code: Code OLZ
Advisory panel: Neurology
Date received: 2016-09-20
Decision date: 2017-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

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