ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)— 510(k) K242754
Substantially EquivalentZamar Medical D.O.O.
FDA 510(k) clearance K242754 for ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A), Substantially Equivalent on 2025-05-05. Applicant: Zamar Medical D.O.O.. Device class: 2.
Clearance details
- Applicant
- Zamar Medical D.O.O.
- Product code
- Code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vrsar, HR
Recent devices under product code IRP
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