Discovery 24
FDA 510(k) clearance K150498 · decided 2016-01-26
Clearance details
- K-number
- K150498
- Device name
- Discovery 24
- Applicant
- Brainmaster Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-26
- Decision date
- 2016-01-26
- Days to decision
- 334 days
- Clearance type
- Traditional
- Product code
- GWQ
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Bedford, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.