FDA 510(k)

TRANBERG Thermoguide Therapy System

N.º K: K214125 · 2022-09-22

SolicitanteClinical Laserthermia Systems, AB

Fecha de decisión2022-09-22

Código de productoONO

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

TRANBERG Thermoguide Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Laserthermia Systems, AB. It received FDA 510(k) clearance on 2022-09-22 under 510(k) number K214125. The device is classified under product code ONO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TRANBERG Thermoguide Therapy System?

TRANBERG Thermoguide Therapy System is a medical device that received FDA 510(k) clearance on 2022-09-22. The listed applicant is Clinical Laserthermia Systems, AB. The 510(k) number is K214125.

When did TRANBERG Thermoguide Therapy System receive FDA 510(k) clearance?

TRANBERG Thermoguide Therapy System received FDA 510(k) clearance on 2022-09-22, under 510(k) number K214125.

Who is the listed applicant for TRANBERG Thermoguide Therapy System?

The FDA 510(k) record lists Clinical Laserthermia Systems, AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANBERG Thermoguide Therapy System?

The FDA product code for TRANBERG Thermoguide Therapy System is ONO.

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Otros registros que enlistan a Clinical Laserthermia Systems, AB como solicitante

K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)K201466Tranberg CLS Laser Applicator K163103Tranberg CLS Diffusor Laser Fiber K151569Tranberg CLS Laser Fiber

Dispositivos relacionados (Código: ONO)

K262315NeuroBlate SystemMonteris Medical K260976NeuroBlate SystemMonteris Medical K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)Medtronic Navigation, Inc.K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)Clinical Laserthermia Systems, AB K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation K240877Monteris Medical NeuroBlate SystemMonteris Medical,

Fuente oficial

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