FDA 510(k)

ANI Монитор

Номер K: K142969 · 2016-02-23

Дата решения2016-02-23

Код продуктаDPS

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

ANI Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Mdoloris Medical Systems Sas. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K142969. 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 ANI Monitor?

ANI Monitor is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is Mdoloris Medical Systems Sas. The 510(k) number is K142969.

When did ANI Monitor receive FDA 510(k) clearance?

ANI Monitor received FDA 510(k) clearance on 2016-02-23, under 510(k) number K142969.

Who is the listed applicant for ANI Monitor?

The FDA 510(k) record lists Mdoloris Medical Systems Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANI Monitor?

The FDA product code for ANI Monitor 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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