Clearance Summary
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes received FDA 510(k) clearance under submission number K183574, sponsored by Huntleigh Healthcare , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-09-06.
- Submission: K183574
- Applicant / Sponsor: Huntleigh Healthcare , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2100
- Decision date: 2019-09-06
Classification & Regulation
This clearance is catalogued under FDA product code DPW and 21 CFR 870.2100, within the Cardiovascular review panel as a Class II device.