The following data is part of a premarket notification filed by Innovision Medical, Inc. with the FDA for Laser Imaging Work Station.
| Device ID | K897186 |
| 510k Number | K897186 |
| Device Name: | LASER IMAGING WORK STATION |
| Classification | Lens, Fundus, Hruby, Diagnostic |
| Applicant | INNOVISION MEDICAL, INC. P.O. BOX 40813 Washington, DC 20016 |
| Contact | L Mackeen,phd |
| Correspondent | L Mackeen,phd INNOVISION MEDICAL, INC. P.O. BOX 40813 Washington, DC 20016 |
| Product Code | HJI |
| CFR Regulation Number | 886.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-28 |
| Decision Date | 1990-03-12 |