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 |