The following data is part of a premarket notification filed by Tms Telemedizinische Systeme Gmbh with the FDA for Sensor Mobile Sm 100 Vitaphone 1001r Remos.
| Device ID | K050670 |
| 510k Number | K050670 |
| Device Name: | SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | TMS TELEMEDIZINISCHE SYSTEME GMBH STADLERSTRASSE 14 Chemnitz, DE 09126 |
| Contact | Tilo Borchardt |
| Correspondent | William J Sammons UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-03-15 |
| Decision Date | 2005-03-30 |
| Summary: | summary |