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FDA 510(k)

BIOSLEEP

K-Number: K002622 · 2000-10-23

ApplicantOxford Biosignals Limited
Decision Date2000-10-23
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOSLEEP is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Biosignals Limited. It received FDA 510(k) clearance on 2000-10-23 under 510(k) number K002622. 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 BIOSLEEP?

BIOSLEEP is a medical device that received FDA 510(k) clearance on 2000-10-23. The listed applicant is Oxford Biosignals Limited. The 510(k) number is K002622.

When did BIOSLEEP receive FDA 510(k) clearance?

BIOSLEEP received FDA 510(k) clearance on 2000-10-23, under 510(k) number K002622.

Who is the listed applicant for BIOSLEEP?

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

What is the FDA product code for BIOSLEEP?

The FDA product code for BIOSLEEP is OLZ.

Related Clinical Trials

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Other records listing Oxford Biosignals Limited 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.

K053112BIOSIGNK042309BIOSOMNIA-V3K021485BIOSOMNIA

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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