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FDA 510(k)

SANDMAN ELITE

K-Number: K153353 · 2016-06-23

ApplicantEmbla Systems
Decision Date2016-06-23
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SANDMAN ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Embla Systems. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K153353. 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 SANDMAN ELITE?

SANDMAN ELITE is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Embla Systems. The 510(k) number is K153353.

When did SANDMAN ELITE receive FDA 510(k) clearance?

SANDMAN ELITE received FDA 510(k) clearance on 2016-06-23, under 510(k) number K153353.

Who is the listed applicant for SANDMAN ELITE?

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

What is the FDA product code for SANDMAN ELITE?

The FDA product code for SANDMAN ELITE is OLZ.

Other records listing Embla Systems 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.

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Related Devices (Code: OLZ)

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.

K253390SOMNUM (SOMNUM)Honeynaps Co., Ltd.K253668Onera SleepMap (SLEEPMAP)Onera B.V.K250851Hypnos (369054-200)Cadwell Industries, Inc.K252330DeepRESPNox Medical EhfK250058NEAT 001Brain Electrophysiology Laboratory Company, LLCK241960DeepRESPNox 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.

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