Clearance Summary
TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA received FDA 510(k) clearance under submission number K092164, sponsored by Shenzhen Delicate Electronics Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-05-13.
- Submission: K092164
- Applicant / Sponsor: Shenzhen Delicate Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2010-05-13
Classification & Regulation
This clearance is catalogued under FDA product code OQQ and 21 CFR 892.1570, within the Radiology review panel as a Class II device.