Fecha de decisión2021-02-05
Código de productoDSA
Comité asesorCV
DecisiónSubstantially Equivalent
Resumen del dispositivo
Patient Monitoring Cables is the device name listed in this FDA 510(k) record. The listed applicant is Jkh USA, LLC. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K203635. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Preguntas frecuentes
What is the Patient Monitoring Cables?
Patient Monitoring Cables is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is Jkh USA, LLC. The 510(k) number is K203635.
When did Patient Monitoring Cables receive FDA 510(k) clearance?
Patient Monitoring Cables received FDA 510(k) clearance on 2021-02-05, under 510(k) number K203635.
Who is the listed applicant for Patient Monitoring Cables?
The FDA 510(k) record lists Jkh USA, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Patient Monitoring Cables?
The FDA product code for Patient Monitoring Cables is DSA.
Ensayos clínicos relacionados
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Otros registros que enlistan a Jkh USA, LLC como solicitante
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K203636PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AGK203652Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740DK202851Spo2 SensorK201645Massage Compression BootsK201470Disposable Medical Face MaskK182671Medi-Direct TENS Pen Ver todos los 9 dispositivos →
Dispositivos relacionados (Código: DSA)
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.