FDA 510(k)

EnsoSleep

K-Number: K162627 · 2017-03-31

Decision Date2017-03-31

Product CodeOLZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EnsoSleep is the device name listed in this FDA 510(k) record. The listed applicant is Ensodata, Inc.. It received FDA 510(k) clearance on 2017-03-31 under 510(k) 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. The listed applicant is Ensodata, Inc.. The 510(k) number is K162627.

When did EnsoSleep receive FDA 510(k) clearance?

EnsoSleep received FDA 510(k) clearance on 2017-03-31, under 510(k) number K162627.

Who is the listed applicant for EnsoSleep?

The FDA 510(k) record lists Ensodata, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EnsoSleep?

The FDA product code for EnsoSleep is OLZ.

Other records listing Ensodata, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231355Aurora K210034EnsoSleep

Related Devices (Code: OLZ)

K253390SOMNUM (SOMNUM)Honeynaps Co., Ltd.K253668Onera SleepMap (SLEEPMAP)Onera B.V.K250851Hypnos (369054-200)Cadwell Industries, Inc.K252330DeepRESPNox Medical Ehf K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC K241960DeepRESPNox Medical Ehf

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.