The following data is part of a premarket notification filed by Cardiac Network, Inc. with the FDA for Cardioteam.
| Device ID | K870527 |
| 510k Number | K870527 |
| Device Name: | CARDIOTEAM |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CARDIAC NETWORK, INC. 100 CHOPIN PLAZA SUITE 3110 Miami, FL 33131 |
| Contact | Ingrid Fortun |
| Correspondent | Ingrid Fortun CARDIAC NETWORK, INC. 100 CHOPIN PLAZA SUITE 3110 Miami, FL 33131 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-09 |
| Decision Date | 1987-04-20 |