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, Watch Bp Office Afib (twin200 Afs)..
| Device ID | K101275 |
| 510k Number | K101275 |
| Device Name: | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS). |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MICROLIFE INTELLECTUAL PROPERTY GMBH 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MICROLIFE INTELLECTUAL PROPERTY GMBH 55 NORTHERN BLVD., SUITE 200 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 | 2010-05-06 |
| Decision Date | 2010-05-28 |
| Summary: | summary |