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FDA 510(k)

Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum

K-Number: K200975 · 2020-06-24

ApplicantHuntleigh Healthcare Limited
Decision Date2020-06-24
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum is a medical device manufactured by Huntleigh Healthcare Limited. It received FDA 510(k) clearance on 2020-06-24 under approval number K200975. 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 Antepartum, Sonicaid Team3 Intrapartum?

Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum is a medical device that received FDA 510(k) clearance on 2020-06-24. It is manufactured by Huntleigh Healthcare Limited. The 510(k) number is K200975.

When was Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum approved by the FDA?

Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum received FDA 510(k) clearance on 2020-06-24, under approval number K200975.

What company makes Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum?

Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum is manufactured by Huntleigh Healthcare Limited.

What is the FDA product code for Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum?

The FDA product code for Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum is HGM.

Other Devices by Huntleigh Healthcare Limited

K201425Disposable Intraoperative Probe (DIOP8)

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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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