The following data is part of a premarket notification filed by Protocol Systems, Inc. with the FDA for Propaq Encore 200 Series Monitor With Neonatal Mode And Impedance Pneumography Options.
| Device ID | K951246 |
| 510k Number | K951246 |
| Device Name: | PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS |
| Classification | Monitor, Apnea, Facility Use |
| 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 | FLS |
| Subsequent Product Code | DRT |
| Subsequent Product Code | MHX |
| CFR Regulation Number | 868.2377 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-20 |
| Decision Date | 1996-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094181005 | K951246 | 000 |
| 00732094202090 | K951246 | 000 |