FDA 510(k)

CamAPS FX

K-Number: K232603 · 2024-05-23

Decision Date2024-05-23

Product CodeQJI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CamAPS FX is the device name listed in this FDA 510(k) record. The listed applicant is Camdiab , Ltd.. It received FDA 510(k) clearance on 2024-05-23 under 510(k) 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. The listed applicant is Camdiab , Ltd.. The 510(k) number is K232603.

When did CamAPS FX receive FDA 510(k) clearance?

CamAPS FX received FDA 510(k) clearance on 2024-05-23, under 510(k) number K232603.

Who is the listed applicant for CamAPS FX?

The FDA 510(k) record lists Camdiab , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CamAPS FX?

The FDA product code for CamAPS FX is QJI.

Related Devices (Code: QJI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed K261461Omnipod 6 algorithmInsulet Corporation K260429Control-IQ+ technologyTandem Diabetes Care, Inc.K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed K253585SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.K251152DBLG2Diabeloop

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.