BRAINPORT V100 DEVICE
FDA 510(k) clearance DEN130039 · decided 2015-06-18
Clearance details
- K-number
- DEN130039
- Device name
- BRAINPORT V100 DEVICE
- Applicant
- Wicab, Inc.
- Decision
- Unknown
- Date received
- 2013-08-07
- Decision date
- 2015-06-18
- Days to decision
- 680 days
- Clearance type
- Direct
- Product code
- PIC
- Device class
- 2
- Regulation number
- 886.5905
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Philedelphia, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BrainPort V100 (K152851) | Wicab, Inc. | 2015-12-24 |
Recalls involving this device
No recalls on record reference this clearance.