The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Microlife Upper Arm Automatic Digital Blood Pressure Monitor.
| Device ID | K153077 |
| 510k Number | K153077 |
| Device Name: | Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MICROLIFE INTELLECTUAL PROPERTY GMBH ESPENSTRASSE 139 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 | 2015-10-23 |
| Decision Date | 2016-02-12 |
| Summary: | summary |