The following data is part of a premarket notification filed by Drw Medical, Llc with the FDA for Napa Lp-15 Airway Pressure Monitor.
| Device ID | K172284 |
| 510k Number | K172284 |
| Device Name: | NAPA LP-15 Airway Pressure Monitor |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | DRW Medical, LLC 811 Lincoln Drive Brookhaven, PA 19015 |
| Contact | Dan Tatum |
| Correspondent | Stephen Gorski Imagenix, Inc. S65 W35739 Piper Road Eagle, WI 53119 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-28 |
| Decision Date | 2018-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860898002650 | K172284 | 000 |
| 10860898002633 | K172284 | 000 |
| 00860898002629 | K172284 | 000 |
| 00860898002612 | K172284 | 000 |
| 00860898002605 | K172284 | 000 |