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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K173974
Device Name DROWZLE
Applicant
Resonea, Inc.
11445 E Via Linda
Suite 24
Scottsdale,  AZ  85259
Applicant Contact Ruchir Sehra
Correspondent
Graematter Inc
1324 Clarkson Clayton Center
#332
St Louis,  MO  63011
Correspondent Contact Melissa Walker
Regulation Number868.2375
Classification Product Code
MNR  
Date Received12/29/2017
Decision Date 07/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT03288376
Reviewed by Third Party No
Combination Product No
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