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FDA 510(k)

Tzoar 207 Negative Pressure Wound Therapy (NPWT) System

N.º K: K202898 · 2021-12-30

SolicitanteLightstone Medical Products (Ningbo) Co, Ltd.
Fecha de decisión2021-12-30
Código de productoOMP
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Tzoar 207 Negative Pressure Wound Therapy (NPWT) System is the device name listed in this FDA 510(k) record. The listed applicant is Lightstone Medical Products (Ningbo) Co, Ltd.. It received FDA 510(k) clearance on 2021-12-30 under 510(k) number K202898. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tzoar 207 Negative Pressure Wound Therapy (NPWT) System?

Tzoar 207 Negative Pressure Wound Therapy (NPWT) System is a medical device that received FDA 510(k) clearance on 2021-12-30. The listed applicant is Lightstone Medical Products (Ningbo) Co, Ltd.. The 510(k) number is K202898.

When did Tzoar 207 Negative Pressure Wound Therapy (NPWT) System receive FDA 510(k) clearance?

Tzoar 207 Negative Pressure Wound Therapy (NPWT) System received FDA 510(k) clearance on 2021-12-30, under 510(k) number K202898.

Who is the listed applicant for Tzoar 207 Negative Pressure Wound Therapy (NPWT) System?

The FDA 510(k) record lists Lightstone Medical Products (Ningbo) Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tzoar 207 Negative Pressure Wound Therapy (NPWT) System?

The FDA product code for Tzoar 207 Negative Pressure Wound Therapy (NPWT) System is OMP.

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Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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