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FDA 510(k)

Fetal & Maternal Monitor (F15A, F15A Air)

K-Number: K241882 · 2025-08-27

ApplicantEdan Instruments, Inc.
Decision Date2025-08-27
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Fetal & Maternal Monitor (F15A, F15A Air) 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 2025-08-27 under 510(k) number K241882. 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 (F15A, F15A Air)?

Fetal & Maternal Monitor (F15A, F15A Air) is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K241882.

When did Fetal & Maternal Monitor (F15A, F15A Air) receive FDA 510(k) clearance?

Fetal & Maternal Monitor (F15A, F15A Air) received FDA 510(k) clearance on 2025-08-27, under 510(k) number K241882.

Who is the listed applicant for Fetal & Maternal Monitor (F15A, F15A Air)?

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 (F15A, F15A Air)?

The FDA product code for Fetal & Maternal Monitor (F15A, F15A Air) is HGM.

Related Clinical Trials

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.

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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.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)Philips Medizin Systeme Boeblingen GmbH

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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