FDA 510(k)

MIRARI® Cold Plasma System ( GV-M2-01)

Número K: K242553 · 2024-11-21

Data da decisão2024-11-21

Código do produtoPBX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

MIRARI® Cold Plasma System ( GV-M2-01) is the device name listed in this FDA 510(k) record. The listed applicant is General Vibronics, Inc.. It received FDA 510(k) clearance on 2024-11-21 under 510(k) number K242553. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MIRARI® Cold Plasma System ( GV-M2-01)?

MIRARI® Cold Plasma System ( GV-M2-01) is a medical device that received FDA 510(k) clearance on 2024-11-21. The listed applicant is General Vibronics, Inc.. The 510(k) number is K242553.

When did MIRARI® Cold Plasma System ( GV-M2-01) receive FDA 510(k) clearance?

MIRARI® Cold Plasma System ( GV-M2-01) received FDA 510(k) clearance on 2024-11-21, under 510(k) number K242553.

Who is the listed applicant for MIRARI® Cold Plasma System ( GV-M2-01)?

The FDA 510(k) record lists General Vibronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIRARI® Cold Plasma System ( GV-M2-01)?

The FDA product code for MIRARI® Cold Plasma System ( GV-M2-01) is PBX.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: PBX)

K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Quattro Apollo (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.