The following data is part of a premarket notification filed by Dynatech/nevada, Inc. with the FDA for Model 215m Patient Simulator.
| Device ID | K897074 |
| 510k Number | K897074 |
| Device Name: | MODEL 215M PATIENT SIMULATOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | DYNATECH/NEVADA, INC. 2000 ARROWHEAD DR. Carson City, NV 89706 -0403 |
| Contact | D Hendricks |
| Correspondent | D Hendricks DYNATECH/NEVADA, INC. 2000 ARROWHEAD DR. Carson City, NV 89706 -0403 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-22 |
| Decision Date | 1990-05-17 |