The following data is part of a premarket notification filed by Medicor Usa Ltd. with the FDA for Model Rs-3 Radiographic Stand.
Device ID | K861995 |
510k Number | K861995 |
Device Name: | MODEL RS-3 RADIOGRAPHIC STAND |
Classification | Tube Mount, X-ray, Diagnostic |
Applicant | MEDICOR USA LTD. 1400 HOLLY AVE. Columbus, OH 43212 |
Contact | Geza Pataky |
Correspondent | Geza Pataky MEDICOR USA LTD. 1400 HOLLY AVE. Columbus, OH 43212 |
Product Code | IYB |
CFR Regulation Number | 892.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-23 |
Decision Date | 1986-06-19 |