The following data is part of a premarket notification filed by Medical Equipment Designs, Inc. with the FDA for Cardiotrace-i Transtelephonic Ecg Receiv Console.
| Device ID | K911308 |
| 510k Number | K911308 |
| Device Name: | CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | MEDICAL EQUIPMENT DESIGNS, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan MEDICAL EQUIPMENT DESIGNS, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-22 |
| Decision Date | 1991-09-11 |