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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 K210480
Device Name AcuPebble SA
Applicant
Acurable Limited
Finsgate, 5-7 Cranwood Street
London,  GB EC1V 9EE
Applicant Contact Esther Rodriguez-Villegas
Correspondent
Acurable Limited
Finsgate, 5-7 Cranwood Street
London,  GB EC1V 9EE
Correspondent Contact Esther Rodriguez-Villegas
Regulation Number868.2375
Classification Product Code
MNR  
Date Received02/19/2021
Decision Date 07/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT03544086
Reviewed by Third Party No
Combination Product No
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