MiCor A100 Wearable ECG Recorder

FDA 510(k) K162665 · Mitac International Corp.

Substantially Equivalent

510(k) numberK162665

Submission

Device name
MiCor A100 Wearable ECG Recorder
Applicant
Mitac International Corp.
Taoyuan City, TW
Received
September 26, 2016
Decision date
January 26, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPS – Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2340
Specialty
Cardiovascular

Other 510(k)s with product code DPS

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K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional Edan Instruments, Inc.07/02/2026SE
K251670MAC 7 Resting ECG Analysis SystemDPS · Traditional Ge Medical Systems Information Technologies, Inc.01/26/2026SE
K252361AccurECG Analysis System (v2.0)DPS · Traditional Accurkardia, Inc.12/22/2025SE
K252474Withings BeamO (SCT02)DPS · Traditional Withings11/10/2025SE
K250569Cardiologs Holter PlatformDPS · Traditional Philips France Commercial08/06/2025SE
K243252ZBPro DiagnosticDPS · Traditional Zbeats, Inc.07/10/2025SE
K243305Masimo W1DPS · Traditional Masimo Corporation04/03/2025SE
K241217CloudHRV™ System (100-01-001)DPS · Traditional Inmedix, Inc.01/16/2025SE
K241556Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional Philips Medizin Systeme Böblingen GmbH12/17/2024SE
K240229Masimo W1DPS · Traditional Masimo Corporation08/08/2024SE

Questions and answers

When was MiCor A100 Wearable ECG Recorder cleared by the FDA?

MiCor A100 Wearable ECG Recorder (K162665) received a 510(k) decision of Substantially Equivalent on January 26, 2018, 487 days after the submission was received.

What is the product code of K162665?

The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.