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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 K231355
Device Name Aurora
Applicant
EnsoData
10 E Doty St., Suite 449
Madison,  WI  53703
Applicant Contact Sigrid Schoepel
Correspondent
EnsoData
10 E Doty St., Suite 449
Madison,  WI  53703
Correspondent Contact Sigrid Schoepel
Regulation Number868.2375
Classification Product Code
MNR  
Date Received05/10/2023
Decision Date 02/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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