The following data is part of a premarket notification filed by Ningbo Diaier Electronic Co., Ltd. with the FDA for Blood Pressure Monitor/ Models.
| Device ID | K093739 |
| 510k Number | K093739 |
| Device Name: | BLOOD PRESSURE MONITOR/ MODELS |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NINGBO DIAIER ELECTRONIC CO., LTD. YAOXI INDUSTRIAL ZONE Yuyao City, Zhejiang, CN |
| Contact | Lao Xikun |
| Correspondent | Lao Xikun NINGBO DIAIER ELECTRONIC CO., LTD. YAOXI INDUSTRIAL ZONE Yuyao City, Zhejiang, CN |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-04 |
| Decision Date | 2010-05-07 |
| Summary: | summary |