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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, programmable
510(k) Number K231620
Device Name Nuubo Smart
Applicant
Smart Solutions Technologies SL
Paseo de la Castellena 200
Madrid,  ES 28046
Applicant Contact Borja Gonzal Vez
Correspondent
ENEM Consulting LLC
556 Lowell Street
Lexington,  MA  02420
Correspondent Contact Nandini Murthy
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DSH   DXH  
Date Received06/02/2023
Decision Date 08/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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