The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Jedmed Ccd-02 Video Camera System.
| Device ID | K862034 |
| 510k Number | K862034 |
| Device Name: | JEDMED CCD-02 VIDEO CAMERA SYSTEM |
| Classification | Camera, Television, Microsurgical, Without Audio |
| Applicant | JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Contact | Craig Rapp |
| Correspondent | Craig Rapp JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Product Code | FWD |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-29 |
| Decision Date | 1986-06-09 |