The following data is part of a premarket notification filed by Electronic Monitoring Devices, Inc. with the FDA for Emd Transtelephonic Recorder And Receiver # 1200.
| Device ID | K920765 |
| 510k Number | K920765 |
| Device Name: | EMD TRANSTELEPHONIC RECORDER AND RECEIVER # 1200 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | ELECTRONIC MONITORING DEVICES, INC. 229 N. LOWELL AVE. Syracuse, NY 13204 |
| Contact | Stephen Esposito |
| Correspondent | Stephen Esposito ELECTRONIC MONITORING DEVICES, INC. 229 N. LOWELL AVE. Syracuse, NY 13204 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-19 |
| Decision Date | 1992-07-07 |