The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Wrist Watch Blood Pressure Monitor Model Bp3gk1-4b.
| Device ID | K211288 |
| 510k Number | K211288 |
| Device Name: | Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Microlife Intellectual Property GmbH Espenstrasse 139 Widnau, CH 9443 |
| Contact | Gerhard Firck |
| Correspondent | Vaibhav Arvind Rajal mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-28 |
| Decision Date | 2021-11-04 |