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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 the device name listed in this FDA 510(k) record. The listed applicant is Onera B.V.. It received FDA 510(k) clearance on 2026-03-08 under 510(k) 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. The listed applicant is Onera B.V.. The 510(k) number is K253668.

When did Onera SleepMap (SLEEPMAP) receive FDA 510(k) clearance?

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

Who is the listed applicant for Onera SleepMap (SLEEPMAP)?

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

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

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

Other records listing Onera B.V. 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.

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

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.K250851Hypnos (369054-200)Cadwell Industries, Inc.K252330DeepRESPNox Medical EhfK250058NEAT 001Brain Electrophysiology Laboratory Company, LLCK241960DeepRESPNox Medical EhfK242094Dreem 3SBeacon Biosignals, Inc.

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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