The following data is part of a premarket notification filed by Vitasystems Gmbh with the FDA for Vitaphone. Model 100 Bt.
| Device ID | K100383 |
| 510k Number | K100383 |
| Device Name: | VITAPHONE. MODEL 100 BT |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | VITASYSTEMS GMBH STADLERSTRASSE 14 Chemnitz, DE 09126 |
| Contact | Tilo Borchardt |
| Correspondent | Tilo Borchardt VITASYSTEMS GMBH STADLERSTRASSE 14 Chemnitz, DE 09126 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-04-20 |
| Summary: | summary |