The following data is part of a premarket notification filed by Protocol Systems, Inc. with the FDA for Propaq 102,104,106,102el,104el,&106el.
| Device ID | K914838 |
| 510k Number | K914838 |
| Device Name: | PROPAQ 102,104,106,102EL,104EL,&106EL |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7101 |
| Contact | Lee A.taylor |
| Correspondent | Lee A.taylor PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7101 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-25 |
| Decision Date | 1992-01-10 |