FDA 510(k)

CAS-One IR

K-Number: K232022 · 2024-03-13

Decision Date2024-03-13

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CAS-One IR is a medical device manufactured by Cascination AG. It received FDA 510(k) clearance on 2024-03-13 under approval number K232022. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAS-One IR?

CAS-One IR is a medical device that received FDA 510(k) clearance on 2024-03-13. It is manufactured by Cascination AG. The 510(k) number is K232022.

When was CAS-One IR approved by the FDA?

CAS-One IR received FDA 510(k) clearance on 2024-03-13, under approval number K232022.

What company makes CAS-One IR?

CAS-One IR is manufactured by Cascination AG.

What is the FDA product code for CAS-One IR?

The FDA product code for CAS-One IR is JAK.

Other Devices by Cascination AG

K152473CAS-One IR K203486Otoplan K220300OTOPLAN K242120OTOPLAN

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.