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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 St.
London,  GB EC1V 9EE
Applicant Contact Esther Rodriguez-Villegas
Correspondent
Acurable Limited
Finsgate, 5-7 Cranwood St.
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
Predetermined Change
Control Plan Authorized		 No
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