FDA.report

510(k) K242094

Device
Dreem 3S
Applicant
Beacon Biosignals, Inc.
510(k) number
K242094
Product code
OLZ
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-22
Date received
2024-07-17
Regulation
882.1400
Classification name
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Alexander Chan
Address
22 Boston Wharf Rd. 7th Floor, Unit 41 Boston MA US 02210 02210

FDA Registration Numbers

Source Documents

510(k) summary PDF

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