The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for The Karl Storz Mini 9000 Solid State Ccd Video Cam.
| Device ID | K881014 |
| 510k Number | K881014 |
| Device Name: | THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Contact | Robert R Giorgini |
| Correspondent | Robert R Giorgini KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-10 |
| Decision Date | 1988-04-14 |