The following data is part of a premarket notification filed by Dynatech/nevada, Inc. with the FDA for Model Ecg100 Simulator.
| Device ID | K897029 |
| 510k Number | K897029 |
| Device Name: | MODEL ECG100 SIMULATOR |
| Classification | Electrocardiograph |
| Applicant | DYNATECH/NEVADA, INC. 2000 ARROWHEAD DR. Carson City, NV 89706 -0403 |
| Contact | Thomas D Hendricks |
| Correspondent | Thomas D Hendricks DYNATECH/NEVADA, INC. 2000 ARROWHEAD DR. Carson City, NV 89706 -0403 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-18 |
| Decision Date | 1990-04-26 |