SleepStageML— 510(k) K233438
Substantially EquivalentBeacon Biosignals, Inc.
FDA 510(k) clearance K233438 for SleepStageML, Substantially Equivalent on 2024-03-08. Applicant: Beacon Biosignals, Inc.. Device class: 2.
Clearance details
- Applicant
- Beacon Biosignals, Inc.
- Product code
- Code OLZ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
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