FDA 510(k)

HeRO Symphony, HeRO ES, HeRO solo/duet

Номер K: K180242 · 2018-02-28

ЗаявительMedical Predictive Science Corporation

Дата решения2018-02-28

Код продуктаDPS

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

HeRO Symphony, HeRO ES, HeRO solo/duet is the device name listed in this FDA 510(k) record. The listed applicant is Medical Predictive Science Corporation. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K180242. 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 HeRO Symphony, HeRO ES, HeRO solo/duet?

HeRO Symphony, HeRO ES, HeRO solo/duet is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Medical Predictive Science Corporation. The 510(k) number is K180242.

When did HeRO Symphony, HeRO ES, HeRO solo/duet receive FDA 510(k) clearance?

HeRO Symphony, HeRO ES, HeRO solo/duet received FDA 510(k) clearance on 2018-02-28, under 510(k) number K180242.

Who is the listed applicant for HeRO Symphony, HeRO ES, HeRO solo/duet?

The FDA 510(k) record lists Medical Predictive Science Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HeRO Symphony, HeRO ES, HeRO solo/duet?

The FDA product code for HeRO Symphony, HeRO ES, HeRO solo/duet 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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