The following data is part of a premarket notification filed by Protocol Systems, Inc. with the FDA for Propaq Monitors, Modification.
| Device ID | K921497 |
| 510k Number | K921497 |
| Device Name: | PROPAQ MONITORS, MODIFICATION |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7101 |
| Contact | James W Sandberg |
| Correspondent | James W Sandberg PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7101 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-11 |
| Decision Date | 1993-03-23 |