Clearance Summary
DOPPLEX-PLB & PXB received FDA 510(k) clearance under submission number K810115, sponsored by Huntleigh Technology, Inc.. 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 1981-07-16.
- Submission: K810115
- Applicant / Sponsor: Huntleigh Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 1981-07-16
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.