The following data is part of a premarket notification filed by Microlife Intellectual Property Gmbh with the FDA for Probp 2400 Digital Blood Pressure Device.
| Device ID | K152770 |
| 510k Number | K152770 |
| Device Name: | ProBP 2400 Digital Blood Pressure Device |
| 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. Great Neck, NY 11021 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-25 |
| Decision Date | 2015-10-21 |
| Summary: | summary |