The following data is part of a premarket notification filed by Integrated Medical Devices, Inc. with the FDA for Imd Psd 410 Pacemaker Transmitter.
| Device ID | K943995 |
| 510k Number | K943995 |
| Device Name: | IMD PSD 410 PACEMAKER TRANSMITTER |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | INTEGRATED MEDICAL DEVICES, INC. 472 SOUTH SALINA ST. SUITE 701 Syracuse, NY 13202 -2403 |
| Contact | Stephen L Esposito |
| Correspondent | Stephen L Esposito INTEGRATED MEDICAL DEVICES, INC. 472 SOUTH SALINA ST. SUITE 701 Syracuse, NY 13202 -2403 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1995-03-07 |