BrainPort V100
FDA 510(k) clearance K152851 · decided 2015-12-24
Clearance details
- K-number
- K152851
- Device name
- BrainPort V100
- Applicant
- Wicab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-29
- Decision date
- 2015-12-24
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- PIC
- Device class
- 2
- Regulation number
- 886.5905
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Middleton, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Wicab
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BRAINPORT V100 DEVICE (DEN130039) | Wicab, Inc. | 2015-06-18 |
Recalls involving this device
No recalls on record reference this clearance.