The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Paceline Patient Transmitter Model 324.
| Device ID | K831443 |
| 510k Number | K831443 |
| Device Name: | PACELINE PATIENT TRANSMITTER MODEL 324 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | PACESETTER SYSTEMS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-05 |
| Decision Date | 1983-08-12 |