FDA 510(k)

MiCor A100 Устройство для ношения ЭКГ

Номер K: K162665 · 2018-01-26

Дата решения2018-01-26

Код продуктаDPS

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

MiCor A100 Wearable ECG Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Mitac International Corp.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K162665. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the MiCor A100 Wearable ECG Recorder?

MiCor A100 Wearable ECG Recorder is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Mitac International Corp.. The 510(k) number is K162665.

When did MiCor A100 Wearable ECG Recorder receive FDA 510(k) clearance?

MiCor A100 Wearable ECG Recorder received FDA 510(k) clearance on 2018-01-26, under 510(k) number K162665.

Who is the listed applicant for MiCor A100 Wearable ECG Recorder?

The FDA 510(k) record lists Mitac International Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiCor A100 Wearable ECG Recorder?

The FDA product code for MiCor A100 Wearable ECG Recorder is DPS.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: DPS)

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Система анализа ЭКГ (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs Holter PlatformPhilips France Commercial

Официальный источник

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