The following data is part of a premarket notification filed by Shenzhen Delicate Electronics Co., Ltd. with the FDA for Transcranial And Vascular Doppler Diagnotic Ultrasound Transducers, Model Ems-9ua.
| Device ID | K092164 |
| 510k Number | K092164 |
| Device Name: | TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA |
| Classification | Diagnostic Ultrasonic Transducer, Robotic |
| Applicant | SHENZHEN DELICATE ELECTRONICS CO., LTD. 1 ODELL PLAZA Yonkers, NY 10701 |
| Contact | William Stern |
| Correspondent | William Stern SHENZHEN DELICATE ELECTRONICS CO., LTD. 1 ODELL PLAZA Yonkers, NY 10701 |
| Product Code | OQQ |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-16 |
| Decision Date | 2010-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970481940031 | K092164 | 000 |