CamAPS FX
K-Number: K232603 · 2024-05-23
ApplicantCamdiab , Ltd.
Decision Date2024-05-23
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
CamAPS FX is a medical device manufactured by Camdiab , Ltd.. It received FDA 510(k) clearance on 2024-05-23 under approval number K232603. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CamAPS FX?
CamAPS FX is a medical device that received FDA 510(k) clearance on 2024-05-23. It is manufactured by Camdiab , Ltd.. The 510(k) number is K232603.
When was CamAPS FX approved by the FDA?
CamAPS FX received FDA 510(k) clearance on 2024-05-23, under approval number K232603.
What company makes CamAPS FX?
CamAPS FX is manufactured by Camdiab , Ltd..
What is the FDA product code for CamAPS FX?
The FDA product code for CamAPS FX is QJI.
Related Devices (Code: QJI)
DEN190034Control-IQ TechnologyTandem Diabetes Care, Inc.
K200467Control-IQ TechnologyTandem Diabetes Care, Inc.
K220394SmartAdjust(TM) technologyInsulet Corporation
K203774SmartAdjust technologyInsulet Corporation
K232382Control-IQ TechnologyTandem Diabetes Care, Inc.
K232224iLet® Dosing Decision SoftwareBeta Bionics, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.