The following data is part of a premarket notification filed by I.e.m. Gmbh with the FDA for Stabil-o-graph.
| Device ID | K041313 |
| 510k Number | K041313 |
| Device Name: | STABIL-O-GRAPH |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-17 |
| Decision Date | 2004-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04041346021027 | K041313 | 000 |
| 04041346021010 | K041313 | 000 |
| 04041346020006 | K041313 | 000 |