The following data is part of a premarket notification filed by Little Doctor (shanghai) Electronic Manufacturing with the FDA for Ld8 Digital Wrist Blood Pressure Monitor.
| Device ID | K070825 |
| 510k Number | K070825 |
| Device Name: | LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | LITTLE DOCTOR (SHANGHAI) ELECTRONIC MANUFACTURING ROOM C,FLOOR 22, ZHIYUAN BLDG NO. 768 XIETU ROAD Shanghai, CN 20023 |
| Contact | David Zhang |
| Correspondent | David Zhang LITTLE DOCTOR (SHANGHAI) ELECTRONIC MANUFACTURING ROOM C,FLOOR 22, ZHIYUAN BLDG NO. 768 XIETU ROAD Shanghai, CN 20023 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-05-25 |
| Summary: | summary |