Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare Limited. It received FDA 510(k) clearance on 2020-06-24 under 510(k) 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. The listed applicant is Huntleigh Healthcare Limited. The 510(k) number is K200975.

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

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

Who is the listed applicant for Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum?

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

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 records listing Huntleigh Healthcare Limited 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.

K250777Sonicaid Team3K241368Sonicaid Team3K211200WoundExpressK201425Disposable Intraoperative Probe (DIOP8)K183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesK152228Hydroven 12, Hydroven 12 Garments

View all 7 devices →

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.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.

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.

↑