The following data is part of a premarket notification filed by Shanghai Little Doctor Electronic Co., Ltd with the FDA for Digital Blood Pressure Monitor.
| Device ID | K092719 |
| 510k Number | K092719 |
| Device Name: | DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHANGHAI LITTLE DOCTOR ELECTRONIC CO., LTD NO.8 TONGXING ROAD, NANTONG ECONOMIC& TECH DEVELOPMENT Nantong, Jiangsu, CN 226007 |
| Contact | Selina Qian |
| Correspondent | Marc Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-09-03 |
| Decision Date | 2009-09-18 |