Clearance Summary
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) received FDA 510(k) clearance under submission number K220245, sponsored by Contec Medical Systems Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2022-09-28.
- Submission: K220245
- Applicant / Sponsor: Contec Medical Systems Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 2022-09-28
Classification & Regulation
This clearance is catalogued under FDA product code KNG and 21 CFR 884.2660, within the Obstetrics/Gynecology review panel as a Class II device.