510(k) K122710
K122710 is an FDA 510(k) premarket notification submitted by Shenzhen Delicate Electronics Co., Ltd. for the device "TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND". The FDA issued a decision of Substantially Equivalent on February 15, 2013. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Shenzhen Delicate Electronics Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 2013
- Date Received
- September 4, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type