The following data is part of a premarket notification filed by Protocol Systems, Inc. with the FDA for Propaq 200 Monitor.
| Device ID | K945071 |
| 510k Number | K945071 |
| Device Name: | PROPAQ 200 MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7101 |
| Contact | James Welch |
| Correspondent | James Welch PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7101 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-14 |
| Decision Date | 1995-05-10 |