Submission Details
| 510(k) Number | K172284 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 28, 2017 |
| Decision Date | February 09, 2018 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
NAPA LP-15 Airway Pressure Monitor
Feb 2018
Decision
196d
Days
Class 2
Risk
About This 510(k) Submission
K172284 is an FDA 510(k) clearance for the NAPA LP-15 Airway Pressure Monitor, a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II — Special Controls, product code CAP), submitted by Drw Medical, LLC (Brookhaven, US). The FDA issued a Cleared decision on February 9, 2018, 196 days after receiving the submission on July 28, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2600.
Device Classification
| Product Code | CAP — Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.2600 |
Manufacturer
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