FDA 510(k)

CAS-One IR

K-Number: K152473 · 2016-01-20

Decision Date2016-01-20

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CAS-One IR is the device name listed in this FDA 510(k) record. The listed applicant is Cascination AG. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K152473. 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 2016-01-20. The listed applicant is Cascination AG. The 510(k) number is K152473.

When did CAS-One IR receive FDA 510(k) clearance?

CAS-One IR received FDA 510(k) clearance on 2016-01-20, under 510(k) number K152473.

Who is the listed applicant for CAS-One IR?

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

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

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

Other records listing Cascination AG as applicant

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.

K242120OTOPLAN K232022CAS-One IR K220300OTOPLAN K203486Otoplan

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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.