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FDA 510(k)

FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS

K-Number: K100797 · 2010-11-10

ApplicantEdan Instruments, Inc.
Decision Date2010-11-10
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2010-11-10 under 510(k) number K100797. 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 FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS?

FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS is a medical device that received FDA 510(k) clearance on 2010-11-10. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K100797.

When did FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS receive FDA 510(k) clearance?

FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS received FDA 510(k) clearance on 2010-11-10, under 510(k) number K100797.

Who is the listed applicant for FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS?

The FDA 510(k) record lists Edan Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS?

The FDA product code for FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS is HGM.

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Other records listing Edan Instruments, Inc. as applicant

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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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