The following data is part of a premarket notification filed by Protocol Systems, Inc. with the FDA for Paq10 Paper Chart Recorder.
| Device ID | K894607 |
| 510k Number | K894607 |
| Device Name: | PAQ10 PAPER CHART RECORDER |
| Classification | Recorder, Paper Chart |
| 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 | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-10-26 |