The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Sd5 & Sd6 Ultrasonic Tabletop Doppler.
| Device ID | K153475 |
| 510k Number | K153475 |
| Device Name: | SD5 & SD6 Ultrasonic Tabletop Doppler |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | EDAN INSTRUMENTS, INC. 3/F - B, NANSHAN MEDICAL EQUIPMENT PARK, NANHAI RD 1019# Shenzhen, CN 518067 |
| Contact | Queena Chen |
| Correspondent | Queena Chen EDAN INSTRUMENTS, INC. 3/F - B, NANSHAN MEDICAL EQUIPMENT PARK, NANHAI RD 1019# Shenzhen, CN 518067 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-02 |
| Decision Date | 2016-01-29 |