The following data is part of a premarket notification filed by Shenzhen Well.d Medical Electronics Co., Ltd with the FDA for Digital Ultrasound Scanner.
Device ID | K100079 |
510k Number | K100079 |
Device Name: | DIGITAL ULTRASOUND SCANNER |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD STE 5D NO.19, LANE 999, ZHONGSHAN NO. 2 ROAD(S) Shanghai, CN 200030 |
Contact | Diana Hong |
Correspondent | Marc Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2010-01-12 |
Decision Date | 2010-03-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06972174670034 | K100079 | 000 |