The following data is part of a premarket notification filed by Protocol Systems, Inc. with the FDA for Propaq Ecg Telemetry Option.
| Device ID | K934711 |
| 510k Number | K934711 |
| Device Name: | PROPAQ ECG TELEMETRY OPTION |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7101 |
| Contact | James P Welch |
| Correspondent | James P Welch PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7101 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-01 |
| Decision Date | 1994-09-01 |