The following data is part of a premarket notification filed by Ningbo Diaier Electronic Co., Ltd. with the FDA for Wa Series: Wa100; Wa200; Wd100; We100, Wf100; Wb200.
| Device ID | K123839 |
| 510k Number | K123839 |
| Device Name: | WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NINGBO DIAIER ELECTRONIC CO., LTD. YAOXI INDUSTRIAL ZONE Yuyao City, Zhejiang, CN 315400 |
| Contact | Lao Xikun |
| Correspondent | Lao Xikun NINGBO DIAIER ELECTRONIC CO., LTD. YAOXI INDUSTRIAL ZONE Yuyao City, Zhejiang, CN 315400 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-13 |
| Decision Date | 2013-01-11 |
| Summary: | summary |