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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
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