The following data is part of a premarket notification filed by I.e.m. Gmbh with the FDA for Mobil-o-graph Ng 24 H Abp-control.
| Device ID | K072446 |
| 510k Number | K072446 |
| Device Name: | MOBIL-O-GRAPH NG 24 H ABP-CONTROL |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | I.E.M. GMBH 11820 RED HIBISCUS DRIVE Bonita Springs, FL 34135 |
| Contact | Guenter Ginsberg |
| Correspondent | Guenter Ginsberg I.E.M. GMBH 11820 RED HIBISCUS DRIVE Bonita Springs, FL 34135 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-30 |
| Decision Date | 2007-11-29 |
| Summary: | summary |