The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler.
| Device ID | K102138 |
| 510k Number | K102138 |
| Device Name: | ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER |
| Classification | Monitor, Fetal Doppler Ultrasound |
| Applicant | EDAN INSTRUMENTS, INC. 3/F-B, NANSHAN MEDICAL EQUIPMENT PARK, NANHAI RD 1019 Shenzhen, CN 518067 |
| Contact | Liu Yongying |
| Correspondent | Liu Yongying EDAN INSTRUMENTS, INC. 3/F-B, NANSHAN MEDICAL EQUIPMENT PARK, NANHAI RD 1019 Shenzhen, CN 518067 |
| Product Code | MAA |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-30 |
| Decision Date | 2010-10-28 |
| Summary: | summary |