FDA 510(k)

Meridian M110 Fetal Monitoring System

Номер K: K161902 · 2017-01-12

Дата решения2017-01-12

Код продуктаHGM

Консультативный комитетOB

РешениеSubstantially Equivalent

Описание устройства

Meridian M110 Fetal Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Mindchild Medical. It received FDA 510(k) clearance on 2017-01-12 under 510(k) number K161902. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Meridian M110 Fetal Monitoring System?

Meridian M110 Fetal Monitoring System is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Mindchild Medical. The 510(k) number is K161902.

When did Meridian M110 Fetal Monitoring System receive FDA 510(k) clearance?

Meridian M110 Fetal Monitoring System received FDA 510(k) clearance on 2017-01-12, under 510(k) number K161902.

Who is the listed applicant for Meridian M110 Fetal Monitoring System?

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

What is the FDA product code for Meridian M110 Fetal Monitoring System?

The FDA product code for Meridian M110 Fetal Monitoring System is HGM.

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: HGM)

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE МатеринскийSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.

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