The following data is part of a premarket notification filed by Shanghai Little Doctor Co. Limited with the FDA for 1103 Digital Blood Pressure Monitor, Model Ld 1103, 1133 Digital Blood Pressure Monitor, Model Ld 1133.
| Device ID | K093359 |
| 510k Number | K093359 |
| Device Name: | 1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133 |
| 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 | 2009-10-28 |
| Decision Date | 2009-11-27 |
| Summary: | summary |