The following data is part of a premarket notification filed by Karl Storz Imaging, Inc. with the FDA for Karl Storz Direct Coupled Interface (dci 5) Camera System.
| Device ID | K990154 |
| 510k Number | K990154 |
| Device Name: | KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM |
| Classification | Camera, Television, Endoscopic, Without Audio |
| 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 | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-19 |
| Decision Date | 1999-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551064320 | K990154 | 000 |
| 04048551064313 | K990154 | 000 |