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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
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