The following data is part of a premarket notification filed by Little Doctor Electronic (nantong) Co., Ltd. with the FDA for Wrist Automatic Blood Pressure Monitor.
| Device ID | K123800 |
| 510k Number | K123800 |
| Device Name: | WRIST AUTOMATIC BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. No. 8, Tongxing Road, Nantong Economic & Technological Development Area Nantong, CN 226007 |
| Contact | Selina Qian |
| Correspondent | Selina Qian LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. No. 8, Tongxing Road, Nantong Economic & Technological Development Area Nantong, CN 226007 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970384250916 | K123800 | 000 |
| 06970384250213 | K123800 | 000 |