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FDA 510(k)

ANNE Maternal

K-Number: K253021 · 2026-02-26

ApplicantSibel Health, Inc.
Decision Date2026-02-26
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ANNE Maternal is the device name listed in this FDA 510(k) record. The listed applicant is Sibel Health, Inc.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K253021. 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 ANNE Maternal?

ANNE Maternal is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Sibel Health, Inc.. The 510(k) number is K253021.

When did ANNE Maternal receive FDA 510(k) clearance?

ANNE Maternal received FDA 510(k) clearance on 2026-02-26, under 510(k) number K253021.

Who is the listed applicant for ANNE Maternal?

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

What is the FDA product code for ANNE Maternal?

The FDA product code for ANNE Maternal is HGM.

Other records listing Sibel Health, Inc. 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.

K242842ANNE View, Central HubK240251ANNE ChestK240305ANNE LimbK223711ANNE One

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.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.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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