EPIC ClearView System
FDA 510(k) clearance DEN150004 · decided 2016-07-15
Clearance details
- K-number
- DEN150004
- Device name
- EPIC ClearView System
- Applicant
- Epic Research & Diagnostics, Inc.
- Decision
- Unknown
- Date received
- 2015-01-13
- Decision date
- 2016-07-15
- Days to decision
- 549 days
- Clearance type
- Direct
- Product code
- PNA
- Device class
- 1
- Regulation number
- 882.1561
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.