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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K222577
Device Name TECHFIT Diagnostic Models
Applicant
TECHFIT Digital Surgery Inc.
1511 Aviation Center Pkwy, Suite 220H
Daytona Beach,  FL  32114
Applicant Contact David Garcia-Patino
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/25/2022
Decision Date 01/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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