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FDA 510(k)

FETAL MONITORS, MODELS F2 AND F3

K-Number: K102140 · 2011-01-13

ApplicantEdan Instruments, Inc.
Decision Date2011-01-13
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL MONITORS, MODELS F2 AND F3 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 2011-01-13 under 510(k) number K102140. 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 MONITORS, MODELS F2 AND F3?

FETAL MONITORS, MODELS F2 AND F3 is a medical device that received FDA 510(k) clearance on 2011-01-13. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K102140.

When did FETAL MONITORS, MODELS F2 AND F3 receive FDA 510(k) clearance?

FETAL MONITORS, MODELS F2 AND F3 received FDA 510(k) clearance on 2011-01-13, under 510(k) number K102140.

Who is the listed applicant for FETAL MONITORS, MODELS F2 AND F3?

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 MONITORS, MODELS F2 AND F3?

The FDA product code for FETAL MONITORS, MODELS F2 AND F3 is HGM.

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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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