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 | K170151 |
510k Number | K170151 |
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 | 2017-01-17 |
Decision Date | 2017-10-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06951740517713 | K170151 | 000 |