The following data is part of a premarket notification filed by Vitasystems Gmbh with the FDA for Emma Electronic Monitoring Management.
| Device ID | K153477 |
| 510k Number | K153477 |
| Device Name: | EMMa Electronic Monitoring Management |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | VITASYSTEMS GMBH MARKIRCHER STR. 22 Mannheim, DE 68229 |
| Contact | Michael Rothhaar |
| Correspondent | Michael Rothhaar VITASYSTEMS GMBH MARKIRCHER STR. 22 Mannheim, DE 68229 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-02 |
| Decision Date | 2016-05-25 |
| Summary: | summary |