510(k) K152851
- Device
- BrainPort V100
- Applicant
- WICAB, INC.
- 510(k) number
- K152851
- Product code
- PIC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-12-24
- Date received
- 2015-09-29
- Regulation
- 886.5905
- Classification name
- Oral Electronic Vision Aid
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT BECKMAN
- Address
- 8313 Greenway Blvd., Suite 100 Middleton WI US 53562 53562
Source Documents#
Other 510(k) Records For Product Code PIC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN130039 | BRAINPORT V100 DEVICE | Wicab, Inc. | 2015-06-18 |
Legacy Summary#
summary
FDA Review#
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