The following data is part of a premarket notification filed by Little Doctor Electronic (nantong) Co., Ltd. with the FDA for Digital Blood Pressure Monitor.
| Device ID | K123600 |
| 510k Number | K123600 |
| Device Name: | DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. NO. 8, TONGXING ROAD NANTONG ECONOMIC & TECHNOLOGY DEVELOPMENT ZONE Nantong, Jiangsu, CN 226009 |
| Contact | Selina Qian |
| Correspondent | Selina Qian LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. NO. 8, TONGXING ROAD NANTONG ECONOMIC & TECHNOLOGY DEVELOPMENT ZONE Nantong, Jiangsu, CN 226009 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2013-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20815817012450 | K123600 | 000 |
| 06970384250947 | K123600 | 000 |
| 06970384250633 | K123600 | 000 |
| 06970384250626 | K123600 | 000 |
| 06970384250619 | K123600 | 000 |
| 06970384250183 | K123600 | 000 |