The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Jedmed Mini-mos Video Camera.
Device ID | K862145 |
510k Number | K862145 |
Device Name: | JEDMED MINI-MOS VIDEO CAMERA |
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 | 1986-06-04 |
Decision Date | 1986-06-13 |