The following data is part of a premarket notification filed by Karl Storz Imaging, Inc. with the FDA for Karl Storz Direct Coupled Camera Head.
| Device ID | K973252 |
| 510k Number | K973252 |
| Device Name: | KARL STORZ DIRECT COUPLED CAMERA HEAD |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| 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 | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-29 |
| Decision Date | 1997-11-24 |
| Summary: | summary |