Cleared Traditional

Sonicaid Team3

K241368 · Huntleigh Healthcare , Ltd. · Obstetrics & Gynecology
Feb 2025
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K241368 is an FDA 510(k) clearance for the Sonicaid Team3, a System, Monitoring, Perinatal (Class II — Special Controls, product code HGM), submitted by Huntleigh Healthcare , Ltd. (Cardiff, GB). The FDA issued a Cleared decision on February 3, 2025, 265 days after receiving the submission on May 14, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2740.

Submission Details

510(k) Number K241368 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2024
Decision Date February 03, 2025
Days to Decision 265 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HGM — System, Monitoring, Perinatal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.2740

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