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 |