Fecha de decisión2021-12-28
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent
Resumen del dispositivo
ATM Glove is the device name listed in this FDA 510(k) record. The listed applicant is Phu Duc Huy Production Trading Services Corporation. It received FDA 510(k) clearance on 2021-12-28 under 510(k) number K213016. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Preguntas frecuentes
What is the ATM Glove?
ATM Glove is a medical device that received FDA 510(k) clearance on 2021-12-28. The listed applicant is Phu Duc Huy Production Trading Services Corporation. The 510(k) number is K213016.
When did ATM Glove receive FDA 510(k) clearance?
ATM Glove received FDA 510(k) clearance on 2021-12-28, under 510(k) number K213016.
Who is the listed applicant for ATM Glove?
The FDA 510(k) record lists Phu Duc Huy Production Trading Services Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ATM Glove?
The FDA product code for ATM Glove is LZA.
Ensayos clínicos relacionados
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.
Dispositivos relacionados (Código: LZA)
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.