The following data is part of a premarket notification filed by Paceart, Inc. with the FDA for Paceart Cardiophone.
| Device ID | K931296 |
| 510k Number | K931296 |
| Device Name: | PACEART CARDIOPHONE |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | PACEART, INC. 22 RIVERVIEW DR. Wayne, NJ 07470 |
| Contact | Michael Bergelson |
| Correspondent | Michael Bergelson PACEART, INC. 22 RIVERVIEW DR. Wayne, NJ 07470 |
| Product Code | DXH |
| Subsequent Product Code | DTG |
| Subsequent Product Code | KRE |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-30 |
| Decision Date | 1993-10-01 |