The following data is part of a premarket notification filed by I.e.m. Gmbh with the FDA for Abpm7100.
| Device ID | K140928 |
| 510k Number | K140928 |
| Device Name: | ABPM7100 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | I.E.M. GMBH COCKERILLSTRASSE 69 Stolberg, DE D-52222 |
| Contact | Arne Briest |
| Correspondent | Arne Briest I.E.M. GMBH COCKERILLSTRASSE 69 Stolberg, DE D-52222 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-11 |
| Decision Date | 2014-09-15 |
| Summary: | summary |