The following data is part of a premarket notification filed by Dynatech/nevada, Inc. with the FDA for Medsim 300 Patient Simulator.
| Device ID | K935817 |
| 510k Number | K935817 |
| Device Name: | MEDSIM 300 PATIENT SIMULATOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | DYNATECH/NEVADA, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein DYNATECH/NEVADA, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 -1109 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-02 |
| Decision Date | 1994-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850540007164 | K935817 | 000 |