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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interoperable Automated Glycemic Controller
510(k) Number K203689
Device Name Tidepool Loop
Applicant
Tidepool Project
3340 Hillview Ave.
Palo Alto,  CA  94304
Applicant Contact Howard Look
Correspondent
Tidepool Project
3340 Hillview Ave.
Palo Alto,  CA  94304
Correspondent Contact Howard Look
Regulation Number862.1356
Classification Product Code
QJI  
Date Received12/17/2020
Decision Date 01/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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