The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Diagnostic Ultrasound System.
Device ID | K123249 |
510k Number | K123249 |
Device Name: | DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | EDAN INSTRUMENTS, INC. EQUIPMENTS PARK, NANHAI RD 1019 NO. SHEKOU NANSHAN Shenzhen, CN 518067 |
Contact | Randy Jiang |
Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2012-10-17 |
Decision Date | 2013-02-08 |
Summary: | summary |