FDA 510(k)

CardioBand ECG Event Recorder

N.º K: K181998 · 2018-11-15

SolicitanteSamsung Strategy and Innovation Center (Ssic)

Fecha de decisión2018-11-15

Código de productoDPS

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

CardioBand ECG Event Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Strategy and Innovation Center (Ssic). It received FDA 510(k) clearance on 2018-11-15 under 510(k) number K181998. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CardioBand ECG Event Recorder?

CardioBand ECG Event Recorder is a medical device that received FDA 510(k) clearance on 2018-11-15. The listed applicant is Samsung Strategy and Innovation Center (Ssic). The 510(k) number is K181998.

When did CardioBand ECG Event Recorder receive FDA 510(k) clearance?

CardioBand ECG Event Recorder received FDA 510(k) clearance on 2018-11-15, under 510(k) number K181998.

Who is the listed applicant for CardioBand ECG Event Recorder?

The FDA 510(k) record lists Samsung Strategy and Innovation Center (Ssic) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CardioBand ECG Event Recorder?

The FDA product code for CardioBand ECG Event Recorder is DPS.

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Fuente oficial

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