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FDA 510(k)

Onera SleepMap (SLEEPMAP)

K-Number: K253668 · 2026-03-08

ApplicantOnera B.V.
Decision Date2026-03-08
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Onera SleepMap (SLEEPMAP) is a medical device manufactured by Onera B.V.. It received FDA 510(k) clearance on 2026-03-08 under approval number K253668. 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 Onera SleepMap (SLEEPMAP)?

Onera SleepMap (SLEEPMAP) is a medical device that received FDA 510(k) clearance on 2026-03-08. It is manufactured by Onera B.V.. The 510(k) number is K253668.

When was Onera SleepMap (SLEEPMAP) approved by the FDA?

Onera SleepMap (SLEEPMAP) received FDA 510(k) clearance on 2026-03-08, under approval number K253668.

What company makes Onera SleepMap (SLEEPMAP)?

Onera SleepMap (SLEEPMAP) is manufactured by Onera B.V..

What is the FDA product code for Onera SleepMap (SLEEPMAP)?

The FDA product code for Onera SleepMap (SLEEPMAP) is OLZ.

Other Devices by Onera B.V.

K210593Onera Sleep Test System (Onera STS) K223573Onera Sleep Test System (Onera STS) K243220Onera STS 2 (ONERA STS 2)

Related Devices (Code: OLZ)

K162140RemLogicEmbla Systems K153353SANDMAN ELITEEmbla Systems K153412Sleep ProfilerAdvanced Brain Monitoring, Inc. K163617REMbrandtEmbla Systems K162627EnsoSleepEnsodata, Inc. K173366NicoletOneNatus Neurology Incorporated

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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