BNA Platform
FDA 510(k) clearance K202588 · decided 2020-12-07
Clearance details
- K-number
- K202588
- Device name
- BNA Platform
- Applicant
- Elminda, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-08
- Decision date
- 2020-12-07
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- OLU
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Herzliya, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.