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FDA 510(k)

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger

Número K: K212065 · 2021-10-07

RequerenteRemington Medical, Inc.
Data da decisão2021-10-07
Código do produtoDPW
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger is the device name listed in this FDA 510(k) record. The listed applicant is Remington Medical, Inc.. It received FDA 510(k) clearance on 2021-10-07 under 510(k) number K212065. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger?

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger is a medical device that received FDA 510(k) clearance on 2021-10-07. The listed applicant is Remington Medical, Inc.. The 510(k) number is K212065.

When did VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger receive FDA 510(k) clearance?

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger received FDA 510(k) clearance on 2021-10-07, under 510(k) number K212065.

Who is the listed applicant for VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger?

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

What is the FDA product code for VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger?

The FDA product code for VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger is DPW.

Ensaios clínicos relacionados

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Outros registros que listam Remington Medical, Inc. como candidato(a)

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.

K251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerK191315Remington Medical, Inc. Automatic Cutting Needle (NAC)

Dispositivos Relacionados (Código: DPW)

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.

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington Medical, Inc.

Fonte oficial

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