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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K232302
Device Name Pocket III
Applicant
Quantel Medical
11 Rue Du Bois Joli-Cs40015
Cournon D' Auvergne-Cedex,  FR 63808
Applicant Contact Bruno Pages
Correspondent
O'Connell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen O'Connell
Regulation Number892.1560
Classification Product Code
IYO  
Date Received08/01/2023
Decision Date 04/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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