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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K232010
Device Name iTEMPSHIELD
Applicant
AION Biosystems Inc.
12 Plymouth Road
Darien,  CT  06820
Applicant Contact Joseph Azary
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/06/2023
Decision Date 08/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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