The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Ek Combi Msg-1.
| Device ID | K830410 |
| 510k Number | K830410 |
| Device Name: | EK COMBI MSG-1 |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | JEDMED INSTRUMENT CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-08 |
| Decision Date | 1983-04-27 |