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FDA 510(k)

BIOSOMNIA

K-Number: K021485 · 2002-09-11

ApplicantOxford Biosignals Limited
Decision Date2002-09-11
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOSOMNIA 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 2002-09-11 under 510(k) number K021485. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSOMNIA?

BIOSOMNIA is a medical device that received FDA 510(k) clearance on 2002-09-11. The listed applicant is Oxford Biosignals Limited. The 510(k) number is K021485.

When did BIOSOMNIA receive FDA 510(k) clearance?

BIOSOMNIA received FDA 510(k) clearance on 2002-09-11, under 510(k) number K021485.

Who is the listed applicant for BIOSOMNIA?

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 BIOSOMNIA?

The FDA product code for BIOSOMNIA is OMC.

Related Clinical Trials

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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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-V3K002622BIOSLEEP

Related Devices (Code: OMC)

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.

K261101Ceribell MonitorCeribell, Inc.K251550NX01 (NX01)Naox Technologies SasK251726SignalNED System (Model RE)Forest Devices, Inc.K243185REMI Remote EEG Monitoring SystemEpitelK242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K232779QUEX ED; QUEX SQx World, Ltd.

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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