The following data is part of a premarket notification filed by Shanghai Little Doctor Co. Limited with the FDA for Digital Wrist Blood Pressure Monitor, Model Ld 1143.
| Device ID | K092683 |
| 510k Number | K092683 |
| Device Name: | DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SHANGHAI LITTLE DOCTOR CO. LIMITED NO. 8 TONGXING ROAD Nantong, Jiangsu, CN 26007 |
| Contact | Janusun Wang |
| Correspondent | Janusun Wang SHANGHAI LITTLE DOCTOR CO. LIMITED NO. 8 TONGXING ROAD Nantong, Jiangsu, CN 26007 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-01 |
| Decision Date | 2009-09-25 |