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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K243837
Device Name iBSM
Applicant
Iorbit Digital Technologies Private Limited
4th Floor, Nagamma Devi Complex, Site # 22,
Survey # 81/2e, Bannerghatta Main Rd.
Bangalore,  IN 560076
Applicant Contact Sandeep Zende
Correspondent
Iorbit Digital Technologies Private Limited
4th Floor, Nagamma Devi Complex, Site # 22,
Survey # 81/2e, Bannerghatta Main Rd.
Bangalore,  IN 560076
Correspondent Contact Sandeep Zende
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
BZQ   DQA   DXN   FLL   KMI  
MWI   MWJ  
Date Received12/13/2024
Decision Date 05/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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