FDA 510(k)

Sonicaid Team3

K-Number: K241368 · 2025-02-03

Decision Date2025-02-03

Product CodeHGM

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Sonicaid Team3 is a medical device manufactured by Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2025-02-03 under approval number K241368. 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 Sonicaid Team3?

Sonicaid Team3 is a medical device that received FDA 510(k) clearance on 2025-02-03. It is manufactured by Huntleigh Healthcare , Ltd.. The 510(k) number is K241368.

When was Sonicaid Team3 approved by the FDA?

Sonicaid Team3 received FDA 510(k) clearance on 2025-02-03, under approval number K241368.

What company makes Sonicaid Team3?

Sonicaid Team3 is manufactured by Huntleigh Healthcare , Ltd..

What is the FDA product code for Sonicaid Team3?

The FDA product code for Sonicaid Team3 is HGM.

Other Devices by Huntleigh Healthcare , Ltd.

K152228Hydroven 12, Hydroven 12 Garments K183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes K211200WoundExpress K250777Sonicaid Team3

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.