FDA 510(k)

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software

N.º K: K162503 · 2017-03-24

Fecha de decisión2017-03-24

Código de productoDSH

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Insight, Inc.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162503. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software?

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Cardiac Insight, Inc.. The 510(k) number is K162503.

When did Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software receive FDA 510(k) clearance?

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162503.

Who is the listed applicant for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software?

The FDA 510(k) record lists Cardiac Insight, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software?

The FDA product code for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is DSH.

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Fuente oficial

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