The following data is part of a premarket notification filed by Globalcare Medical Technology Co., Ltd with the FDA for Globalcare Blood Pressure Monitor.
| Device ID | K192609 |
| 510k Number | K192609 |
| Device Name: | Globalcare Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Globalcare Medical Technology Co., Ltd No.7 Factory, European Industrial Park, No. 39 Mid Industrial Main Road Xiaolan Town, Zhongshan City, CN 528415 |
| Contact | Janice Deng |
| Correspondent | Roger Gray Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, IT 00153 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-20 |
| Decision Date | 2020-04-21 |