BIOSOMNIA-V3

FDA 510(k) K042309 · Oxford Biosignals Limited

Substantially Equivalent

510(k) numberK042309

Submission

Device name
BIOSOMNIA-V3
Applicant
Oxford Biosignals Limited
Troy, IL, US
Received
August 25, 2004
Decision date
September 8, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
OMC – Reduced- Montage Standard Electroencephalograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1400
Specialty
Neurology

Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes

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Questions and answers

When was BIOSOMNIA-V3 cleared by the FDA?

BIOSOMNIA-V3 (K042309) received a 510(k) decision of Substantially Equivalent on September 8, 2004, 14 days after the submission was received.

What is the product code of K042309?

The FDA product code is OMC – Reduced- Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.