The following data is part of a premarket notification filed by Shenzhen Pango Electronic Co., Ltd. with the FDA for Electronic Blood Pressure Monitor.
| Device ID | K200716 |
| 510k Number | K200716 |
| Device Name: | Electronic Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Pango Electronic Co., Ltd. No.25, 1st Industrial Park, Fenghuang Road Xikeng, Henggang, Longgang District Shenzhen, CN 518115 |
| Contact | Xioyun Yang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-18 |
| Decision Date | 2020-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G467101112BC0 | K200716 | 000 |