The following data is part of a premarket notification filed by Shenzhen Delicate Electronics Co., Ltd. with the FDA for Transcranial Doppler With Robotic Probe Headband.
Device ID | K122710 |
510k Number | K122710 |
Device Name: | TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | SHENZHEN DELICATE ELECTRONICS CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
Contact | Diana Hong |
Correspondent | Diana Hong SHENZHEN DELICATE ELECTRONICS CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | OQQ |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-04 |
Decision Date | 2013-02-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06970481940048 | K122710 | 000 |