The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Cardiomemo Iii.
| Device ID | K830477 |
| 510k Number | K830477 |
| Device Name: | CARDIOMEMO III |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | INSTROMEDIX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-15 |
| Decision Date | 1983-05-09 |