ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)
K-Number: K242754 · 2025-05-05
ApplicantZamar Medical D.O.O.
Decision Date2025-05-05
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) is a medical device manufactured by Zamar Medical D.O.O.. It received FDA 510(k) clearance on 2025-05-05 under approval number K242754. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)?
ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) is a medical device that received FDA 510(k) clearance on 2025-05-05. It is manufactured by Zamar Medical D.O.O.. The 510(k) number is K242754.
When was ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) approved by the FDA?
ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) received FDA 510(k) clearance on 2025-05-05, under approval number K242754.
What company makes ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)?
ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) is manufactured by Zamar Medical D.O.O..
What is the FDA product code for ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)?
The FDA product code for ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) is IRP.
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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.