The following data is part of a premarket notification filed by I.e.m. Industrielle Entwicklung And Medizintechnik with the FDA for Tel-o-graph.
| Device ID | K173895 |
| 510k Number | K173895 |
| Device Name: | Tel-O-Graph |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | I.E.M. Industrielle Entwicklung And Medizintechnik Vertriebsgesellschaft MbH Cockerillstrabe 69 Stolberg, DE 52222 |
| Contact | Hella Witt |
| Correspondent | Hella Witt I.E.M. Industrielle Entwicklung And Medizintechnik Vertriebsgesellschaft MbH Cockerillstrabe 69 Stolberg, DE 52222 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-21 |
| Decision Date | 2019-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04041346101279 | K173895 | 000 |
| 04041346101262 | K173895 | 000 |
| 04041346101231 | K173895 | 000 |
| 04041346101224 | K173895 | 000 |
| 04041346101217 | K173895 | 000 |
| 04041346101200 | K173895 | 000 |
| 04041346102160 | K173895 | 000 |