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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K242553

MIRARI® Cold Plasma System ( GV-M2-01) · General Vibronics, Inc. · decided 2024-11-21 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Insulating Waterproof ePTFE PouchGV-EPTFE-01General Vibronics, LLCGEI PBX00860013508647
MIRARI Cold Plasma System Insulating Fleece PouchGV-FL-01General Vibronics, LLCGEI PBX00860013508623
MIRARI Cold Plasma DriverGVM2General Vibronics, LLCGEI PBX00860013508616
MIRARI Cold Plasma System ArrayGVPA-10BBGeneral Vibronics, LLCGEI PBX00860013508630
MIRARI Cold Plasma unit box setGVM2-01General Vibronics, LLCGEI PBX00860013508609