The following data is part of a premarket notification filed by Iscreen Vision, Inc. with the FDA for Iscreen Vision Screener.
| Device ID | K102651 |
| 510k Number | K102651 |
| Device Name: | ISCREEN VISION SCREENER |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | ISCREEN VISION, INC. 110 TIMBERCREEK DRIVE SUITE# 2 Cordova, TN 38018 |
| Contact | Buck Brown |
| Correspondent | Buck Brown ISCREEN VISION, INC. 110 TIMBERCREEK DRIVE SUITE# 2 Cordova, TN 38018 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-14 |
| Decision Date | 2011-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864218000104 | K102651 | 000 |