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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 K232603
Device Name CamAPS FX
Applicant
Camdiab , Ltd.
20-22 Wenlock Rd.
London,  GB N1 7GU
Applicant Contact Roman Hovorka
Correspondent
MCRA, LLC
803 7th St., NW, 3rd Floor
Washington, Dc,  DC  20001
Correspondent Contact Nima Akhlaghi
Regulation Number862.1356
Classification Product Code
QJI  
Subsequent Product Code
NDC  
Date Received08/28/2023
Decision Date 05/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT00910767
NCT00944619
NCT00989898
NCT01074801
NCT01221467
NCT01440140
NCT01629251
NCT01629277
NCT01666028
NCT01778348
NCT01873066
NCT01961622
NCT02523131
NCT02727231
NCT02871089
NCT02925299
NCT03101865
NCT03784027
NCT04025762
NCT04055480
NCT04938557
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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