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FDA 510(k)

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 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.

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. 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.

Related Devices (Code: DRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

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.

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