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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 K231546
Device Name Somfit
Applicant
Compumedics Limited
30-40 Flockhart St.
Abbotsford,  AU 3067
Applicant Contact Michael Frischman
Correspondent
Compumedics Limited
30-40 Flockhart St.
Abbotsford,  AU 3067
Correspondent Contact Michael Frischman
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Code
OMC  
Date Received05/30/2023
Decision Date 11/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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