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FDA 510(k)

MINDCHILD MERIDIAN FETAL HEART RATE MONITOR

K-Number: K120018 · 2012-09-19

ApplicantMindchild Medical
Decision Date2012-09-19
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MINDCHILD MERIDIAN FETAL HEART RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Mindchild Medical. It received FDA 510(k) clearance on 2012-09-19 under 510(k) number K120018. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINDCHILD MERIDIAN FETAL HEART RATE MONITOR?

MINDCHILD MERIDIAN FETAL HEART RATE MONITOR is a medical device that received FDA 510(k) clearance on 2012-09-19. The listed applicant is Mindchild Medical. The 510(k) number is K120018.

When did MINDCHILD MERIDIAN FETAL HEART RATE MONITOR receive FDA 510(k) clearance?

MINDCHILD MERIDIAN FETAL HEART RATE MONITOR received FDA 510(k) clearance on 2012-09-19, under 510(k) number K120018.

Who is the listed applicant for MINDCHILD MERIDIAN FETAL HEART RATE MONITOR?

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 MINDCHILD MERIDIAN FETAL HEART RATE MONITOR?

The FDA product code for MINDCHILD MERIDIAN FETAL HEART RATE MONITOR is HGM.

Related Clinical Trials

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Other records listing Mindchild Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K161902Meridian M110 Fetal Monitoring System

Related Devices (Code: HGM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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