The following data is part of a premarket notification filed by Karl Storz Imaging, Inc. with the FDA for Optronics Epic Color Television Camera System (s97340).
| Device ID | K963333 |
| 510k Number | K963333 |
| Device Name: | OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | KARL STORZ IMAGING, INC. 175 CREMONA DR. Goleta, CA 93117 |
| Contact | Terry Fernandez |
| Correspondent | Terry Fernandez KARL STORZ IMAGING, INC. 175 CREMONA DR. Goleta, CA 93117 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-23 |
| Decision Date | 1996-10-22 |
| Summary: | summary |