The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh, Switzerland with the FDA for Microlife Wrist Watch Blood Pressure Monitor.
| Device ID | K151330 |
| 510k Number | K151330 |
| Device Name: | Microlife Wrist Watch Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MICROLIFE INTELLECTUAL PROPERTY GmbH, SWITZERLAND ESPENSTRASSE 139, 9443 Widnau, CH 9443 |
| Contact | Gerhard Frick |
| Correspondent | Susan D. Goldstein-falk 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 | 2015-05-19 |
| Decision Date | 2015-07-14 |
| Summary: | summary |