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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, airway pressure (includes gauge and/or alarm)
510(k) Number K172284
Device Name NAPA LP-15 Airway Pressure Monitor
Applicant
DRW Medical, LLC
811 Lincoln Drive
Brookhaven,  PA  19015
Applicant Contact Dan Tatum
Correspondent
Imagenix, Inc.
S65 W35739 Piper Road
Eagle,  WI  53119
Correspondent Contact Stephen Gorski
Regulation Number868.2600
Classification Product Code
CAP  
Date Received07/28/2017
Decision Date 02/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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