Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum— 510(k) K200975
Substantially EquivalentHuntleigh Healthcare Limited
FDA 510(k) clearance K200975 for Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum, Substantially Equivalent on 2020-06-24. Applicant: Huntleigh Healthcare Limited.
Clearance details
- Applicant
- Huntleigh Healthcare Limited
- Product code
- Code HGM
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cardiff, GB
Adverse events under product code HGM
product code HGM- Death
- 35
- Malfunction
- 478
- Total
- 513
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.