FDA 510(k)

EZYPRO ECG Recorder (Model: UG02)

Numéro K : K213233 · 2022-06-23

Date de décision2022-06-23

Code produitDRG

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

EZYPRO ECG Recorder (Model: UG02) is the device name listed in this FDA 510(k) record. The listed applicant is Sigknow Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2022-06-23 under 510(k) number K213233. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the EZYPRO ECG Recorder (Model: UG02)?

EZYPRO ECG Recorder (Model: UG02) is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Sigknow Biomedical Co., Ltd.. The 510(k) number is K213233.

When did EZYPRO ECG Recorder (Model: UG02) receive FDA 510(k) clearance?

EZYPRO ECG Recorder (Model: UG02) received FDA 510(k) clearance on 2022-06-23, under 510(k) number K213233.

Who is the listed applicant for EZYPRO ECG Recorder (Model: UG02)?

The FDA 510(k) record lists Sigknow Biomedical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZYPRO ECG Recorder (Model: UG02)?

The FDA product code for EZYPRO ECG Recorder (Model: UG02) is DRG.

Essais cliniques associés

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Source officielle

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