510(k) DEN130039
- Device
- BRAINPORT V100 DEVICE
- Applicant
- Wicab, Inc.
- 510(k) number
- DEN130039
- Product code
- PIC
- Decision
- Unknown (DENG)
- Decision date
- 2015-06-18
- Date received
- 2013-08-07
- Regulation
- 886.5905
- Classification name
- Oral Electronic Vision Aid
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- STEVEN B DATLOF
- Address
- 1835 Market St., 29th Floor Philedelphia PA US 19103 19103
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PIC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152851 | BrainPort V100 | Wicab, Inc. | 2015-12-24 |