The following data is part of a premarket notification filed by Ams Medical, Inc. with the FDA for Novacor's R-test 60 & R-test 160 Ecg Recorders.
| Device ID | K844391 |
| 510k Number | K844391 |
| Device Name: | NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | AMS MEDICAL, INC. 1105 N. URBANDALE Minneapolis, MN 55447 |
| Contact | Donna S Anderson |
| Correspondent | Donna S Anderson AMS MEDICAL, INC. 1105 N. URBANDALE Minneapolis, MN 55447 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-13 |
| Decision Date | 1985-01-07 |