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FDA 510(k)

Sonicaid Team3

K-Number: K241368 · 2025-02-03

ApplicantHuntleigh Healthcare , Ltd.
Decision Date2025-02-03
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sonicaid Team3 is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2025-02-03 under 510(k) 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. The listed applicant is Huntleigh Healthcare , Ltd.. The 510(k) number is K241368.

When did Sonicaid Team3 receive FDA 510(k) clearance?

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

Who is the listed applicant for Sonicaid Team3?

The FDA 510(k) record lists Huntleigh Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonicaid Team3?

The FDA product code for Sonicaid Team3 is HGM.

Other records listing Huntleigh Healthcare , Ltd. 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.

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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.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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