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FDA 510(k)

Meridian M110 Fetal Monitoring System

K-Number: K161902 · 2017-01-12

ApplicantMindchild Medical
Decision Date2017-01-12
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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

View on FDA Database →

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

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