Report Studio
Beacon Biosignals, Inc. · Neurology
Open FDA's page for this record- Third party flag
- N
- City
- Boston
- Advisory committee description
- Neurology
- Address 1
- 22 Boston Wharf Rd.
- Address 2
- 7th Floor, Unit 41
- Statement or summary
- Summary
- Product code
- OLV
- Zip code
- 02210
- Applicant
- Beacon Biosignals, Inc.
- Decision date
- 2026-08-25
- Decision code
- SESE
- Country code
- US
- Device name
- Report Studio
- Advisory committee
- NE
- Contact
- Tahir Rizvi
- K number
- K261747
- State
- MA
- Date received
- 2026-05-27
- Review advisory committee
- NE
- Postal code
- 02210
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Standard Polysomnograph With Electroencephalograph
- Medical specialty description
- Neurology
- Regulation number
- 882.1400
- Device class
- 2
- Registration number
- 3006258337, 3015491430, 3020018, 3030154814, 3007323246, 3013501110, 9613619, 9617286, 3008253300, 8030229, 3023272766, 3002797442, 3009770872, 2518422, 1063925, 9710486, 3006177498, 9612330, 3002806730, 1530224, 1650946, 3008881376, 9611252, 3026753386, 3021736577, 3038189172, 2184161, 2023374, 1529102, 3011120183, 3005550372, 3001687738, 3027726372, 3005733633, 3006125362, 9615102, 3004964738, 3010611950, 3006418479, 3012428212 +7 more
- FEI number
- 3006258337, 3015491430, 3020018, 3030154814, 3004674371, 1000139867, 3013501110, 3007323246, 3008253300, 3003501123, 3023272766, 3002797442, 3009770872, 2518422, 3006177498, 3002806730, 3008881376, 3026753386, 3021736577, 3038189172, 2023374, 3011120183, 1000271197, 1000160007, 3002807739, 3005550372, 3002809369, 3002807720, 3002716534, 3001687738, 3027726372, 3005733633, 3006125362, 3002459124, 3004964738, 3000206198, 3010611950, 3006418479, 3012428212, 3000126629 +7 more