The following data is part of a premarket notification filed by Ningbo Diaier Electronic Co., Ltd. with the FDA for Blood Pressure Monitor, Model Wa400 For Wrist Type And Model Aa300 For Upper Arm Type.
| Device ID | K091553 |
| 510k Number | K091553 |
| Device Name: | BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NINGBO DIAIER ELECTRONIC CO., LTD. NO. 1 BEIXING ROAD YAOXI INDUSTRIAL ZONE Yuyao City, Zhejiang, CN |
| Contact | Lao Xikun |
| Correspondent | Lao Xikun NINGBO DIAIER ELECTRONIC CO., LTD. NO. 1 BEIXING ROAD YAOXI INDUSTRIAL ZONE Yuyao City, Zhejiang, CN |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-27 |
| Decision Date | 2009-09-21 |
| Summary: | summary |