The following data is part of a premarket notification filed by Cardio Telemetric Systems, Inc. with the FDA for Heart Track.
| Device ID | K864293 |
| 510k Number | K864293 |
| Device Name: | HEART TRACK |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARDIO TELEMETRIC SYSTEMS, INC. 10250 ALLIANCE RD. P.O. BOX 42621 Cincinnati, OH 45242 |
| Contact | Thomas Shoup |
| Correspondent | Thomas Shoup CARDIO TELEMETRIC SYSTEMS, INC. 10250 ALLIANCE RD. P.O. BOX 42621 Cincinnati, OH 45242 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-31 |
| Decision Date | 1987-03-23 |