EZYPRO ECG Recorder (Model: UG02)
K-Number: K213233 · 2022-06-23
ApplicantSigknow Biomedical Co., Ltd.
Decision Date2022-06-23
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
EZYPRO ECG Recorder (Model: UG02) is a medical device manufactured by Sigknow Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2022-06-23 under approval number K213233. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Sigknow Biomedical Co., Ltd.. The 510(k) number is K213233.
When was EZYPRO ECG Recorder (Model: UG02) approved by the FDA?
EZYPRO ECG Recorder (Model: UG02) received FDA 510(k) clearance on 2022-06-23, under approval number K213233.
What company makes EZYPRO ECG Recorder (Model: UG02)?
EZYPRO ECG Recorder (Model: UG02) is manufactured by Sigknow Biomedical Co., Ltd..
What is the FDA product code for EZYPRO ECG Recorder (Model: UG02)?
The FDA product code for EZYPRO ECG Recorder (Model: UG02) is DRG.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.