FDA 510(k)

ANNE Maternal

K-Number: K253021 · 2026-02-26

Decision Date2026-02-26

Product CodeHGM

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

ANNE Maternal is a medical device manufactured by Sibel Health, Inc.. It received FDA 510(k) clearance on 2026-02-26 under approval 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. It is manufactured by Sibel Health, Inc.. The 510(k) number is K253021.

When was ANNE Maternal approved by the FDA?

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

What company makes ANNE Maternal?

ANNE Maternal is manufactured by Sibel Health, Inc..

What is the FDA product code for ANNE Maternal?

The FDA product code for ANNE Maternal is HGM.

Other Devices by Sibel Health, Inc.

K223711ANNE One K240251ANNE Chest K240305ANNE Limb K242842ANNE View, Central Hub

Related Devices (Code: HGM)

K153580Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. K171178Central Monitoring SystemEdan Instruments, Inc. K171865F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer MonitoringFarus, LLC K161902Meridian M110 Fetal Monitoring SystemMindchild Medical K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3Edan Instruments, Inc.

Official Source

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