The following data is part of a premarket notification filed by Vitasystems Gmbh with the FDA for Vitaphone Tele Ecg Loop Recorder.
| Device ID | K151013 |
| 510k Number | K151013 |
| Device Name: | Vitaphone Tele ECG Loop Recorder |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | Vitasystems GmbH Stadlerstrasse 14 Chemnitz, DE D-09126 |
| Contact | Michael Rothhaar |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-04-15 |
| Decision Date | 2015-04-30 |
| Summary: | summary |