The following data is part of a premarket notification filed by Protocol Systems, Inc. with the FDA for Propaq 106(tm).
| Device ID | K884320 |
| 510k Number | K884320 |
| Device Name: | PROPAQ 106(TM) |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | PROTOCOL SYSTEMS, INC. 14924 N.W. GREENBRIER PKWY. Beaverton, OR 97006 |
| Contact | James W Sandberg |
| Correspondent | James W Sandberg PROTOCOL SYSTEMS, INC. 14924 N.W. GREENBRIER PKWY. Beaverton, OR 97006 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-13 |
| Decision Date | 1988-12-27 |