DIOPSYS NOVA VEP VISION TESTING SYSTEM
FDA 510(k) clearance K101763 · decided 2011-05-09
Clearance details
- K-number
- K101763
- Device name
- DIOPSYS NOVA VEP VISION TESTING SYSTEM
- Applicant
- Diopsys, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-23
- Decision date
- 2011-05-09
- Days to decision
- 320 days
- Clearance type
- Traditional
- Product code
- GWE
- Device class
- 2
- Regulation number
- 882.1890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Pine Brook, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.