The following data is part of a premarket notification filed by I.e.m. Gmbh with the FDA for Abpm 7100, Hypertension Management Software.
| Device ID | K153557 |
| 510k Number | K153557 |
| Device Name: | ABPM 7100, Hypertension Management Software |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | I.E.M. GMBH COCKERILLSTR. 69 Stolberg, DE 52222 |
| Contact | Hella Witt |
| Correspondent | Hella Witt I.E.M. GMBH COCKERILLSTR.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 | 2015-12-14 |
| Decision Date | 2016-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04041346031163 | K153557 | 000 |
| 04041346101194 | K153557 | 000 |
| 04041346101187 | K153557 | 000 |
| 04041346101170 | K153557 | 000 |
| 04041346101163 | K153557 | 000 |
| 04041346101156 | K153557 | 000 |
| 04041346101149 | K153557 | 000 |
| 04041346101132 | K153557 | 000 |
| 04041346101064 | K153557 | 000 |
| 04041346101057 | K153557 | 000 |
| 04041346101040 | K153557 | 000 |
| 04041346101033 | K153557 | 000 |
| 04041346101026 | K153557 | 000 |
| 04041346030913 | K153557 | 000 |
| 04041346101255 | K153557 | 000 |
| 04041346100784 | K153557 | 000 |
| 04041346031071 | K153557 | 000 |
| 04041346031064 | K153557 | 000 |
| 04041346031057 | K153557 | 000 |
| 04041346031040 | K153557 | 000 |
| 04041346031033 | K153557 | 000 |
| 04041346031026 | K153557 | 000 |
| 04041346031019 | K153557 | 000 |
| 04041346030562 | K153557 | 000 |
| 04041346030517 | K153557 | 000 |
| 04041346030500 | K153557 | 000 |
| 04041346032405 | K153557 | 000 |
| 04041346030531 | K153557 | 000 |
| 04041346100876 | K153557 | 000 |
| 04041346102054 | K153557 | 000 |