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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 K243092
Device Name AcuPebble Ox (200)
Applicant
Acurable Limited
2 Leman St.
London,  GB E1W 9US
Applicant Contact Esther Rodriguez Villegas
Correspondent
Acurable Limited
2 Leman St.
London,  GB E1W 9US
Correspondent Contact Esther Rodriguez Villegas
Regulation Number868.2375
Classification Product Code
MNR  
Date Received09/30/2024
Decision Date 03/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT06460246
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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