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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
Predetermined Change
Control Plan Authorized		 No
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