510(k) clearance
Report Studio
- 510(k) number
- K261747
- Applicant
- Beacon Biosignals, Inc.
- Decision date
- Aug 25, 2026
- Date received
- May 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OLV
- Device type
- Standard Polysomnograph With Electroencephalograph
- Device class
- Class II
- Regulation
- 21 CFR 882.1400
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Boston, MA, US