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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 K223073
FOIA Releasable 510(k) K223073
Device Name Alio
Applicant
Alio, Inc.
10901 W. 120th Ave., Suite 380
Broomfield,  CO  80021
Applicant Contact Kimberly Snyder
Correspondent
RQM+
2790 Mosside Blvd., Suite 800
Monroeville,,  PA  15146
Correspondent Contact Kevin Go
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Code
DQD  
Date Received09/30/2022
Decision Date 03/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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