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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 K211365
Device Name Alio Medical Remote Monitoring System
Applicant
Graftworx, Inc. Dba Alio
544b Bryant St.
San Francisco,  CA  94107
Applicant Contact David Kuraguntla
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave. Suite B-257
San Diego,  CA  92109
Correspondent Contact Allison Komiyama
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DQD   FLL  
Date Received05/04/2021
Decision Date 03/24/2022
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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