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 | K161845 |
| 510k Number | K161845 |
| 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 | Xiaoyun 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-05 |
| Decision Date | 2017-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000853118 | K161845 | 000 |
| 06948423802778 | K161845 | 000 |
| 06948423802792 | K161845 | 000 |
| 06948423805281 | K161845 | 000 |
| 06948423806004 | K161845 | 000 |
| 06948423806011 | K161845 | 000 |
| 06948423806028 | K161845 | 000 |
| 06948423806059 | K161845 | 000 |
| 06948423806387 | K161845 | 000 |
| 00856324008488 | K161845 | 000 |