Clearance Summary
TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND received FDA 510(k) clearance under submission number K122710, sponsored by Shenzhen Delicate Electronics Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-02-15.
- Submission: K122710
- Applicant / Sponsor: Shenzhen Delicate Electronics Co., Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2013-02-15
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.