The following data is part of a premarket notification filed by Ipco Corp. with the FDA for Ipco M-101 Echocardiograph (ipco Ultra-.
| Device ID | K792373 |
| 510k Number | K792373 |
| Device Name: | IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA- |
| Classification | Echocardiograph |
| Applicant | IPCO CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-26 |
| Decision Date | 1980-02-13 |