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FDA 510(k)

SunTech CT40 Spot-check Vital Signs Device

N.º K: K160439 · 2016-07-06

SolicitanteSuntech Medical
Fecha de decisión2016-07-06
Código de productoDXN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

SunTech CT40 Spot-check Vital Signs Device is the device name listed in this FDA 510(k) record. The listed applicant is Suntech Medical. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K160439. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SunTech CT40 Spot-check Vital Signs Device?

SunTech CT40 Spot-check Vital Signs Device is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is Suntech Medical. The 510(k) number is K160439.

When did SunTech CT40 Spot-check Vital Signs Device receive FDA 510(k) clearance?

SunTech CT40 Spot-check Vital Signs Device received FDA 510(k) clearance on 2016-07-06, under 510(k) number K160439.

Who is the listed applicant for SunTech CT40 Spot-check Vital Signs Device?

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

What is the FDA product code for SunTech CT40 Spot-check Vital Signs Device?

The FDA product code for SunTech CT40 Spot-check Vital Signs Device is DXN.

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Fuente oficial

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