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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 a medical device manufactured by Embla Systems. It received FDA 510(k) clearance on 2016-06-23 under approval 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. It is manufactured by Embla Systems. The 510(k) number is K153353.

When was SANDMAN ELITE approved by the FDA?

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

What company makes SANDMAN ELITE?

SANDMAN ELITE is manufactured by Embla Systems.

What is the FDA product code for SANDMAN ELITE?

The FDA product code for SANDMAN ELITE is OLZ.

Other Devices by Embla Systems

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Related Devices (Code: OLZ)

K162140RemLogicEmbla Systems K153412Sleep ProfilerAdvanced Brain Monitoring, Inc. K163617REMbrandtEmbla Systems K162627EnsoSleepEnsodata, Inc. K173366NicoletOneNatus Neurology Incorporated K192469Nox Sleep SystemNox Medical

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.

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