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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K240139
Device Name Real Intelligence™ CORI™
Applicant
Blue Belt Technologies, Inc.
2828 Railroad St.
Pittsburgh,  PA  15222
Applicant Contact Herlinger Corrine
Correspondent
Blue Belt Technologies, Inc.
2828 Railroad St.
Pittsburgh,  PA  15222
Correspondent Contact Herlinger Corrine
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
HSX   JWH   MBH   NJD  
Date Received01/18/2024
Decision Date 03/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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