The following data is part of a premarket notification filed by Industrielle Entwicklung Medizintechnik Und Vertri with the FDA for Abpm Mobil-o-graph Blood Pressure Monitor, Model Abp Control.
| Device ID | K964235 |
| 510k Number | K964235 |
| Device Name: | ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI 1151 HOPE ST. Stamford, CT 06907 |
| Contact | Uwe Korth |
| Correspondent | Uwe Korth INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI 1151 HOPE ST. Stamford, CT 06907 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-23 |
| Decision Date | 1999-03-02 |
| Summary: | summary |