The following data is part of a premarket notification filed by Biosign Technologies, Inc. with the FDA for Ufit Ten-10.
| Device ID | K122443 |
| 510k Number | K122443 |
| Device Name: | UFIT TEN-10 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BIOSIGN TECHNOLOGIES, INC. 9001 WESLEYAN RD, SUITE 200 Indianapolis, IN 46268 |
| Contact | Allison Scott, Rac |
| Correspondent | Allison Scott, Rac BIOSIGN TECHNOLOGIES, INC. 9001 WESLEYAN RD, SUITE 200 Indianapolis, IN 46268 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-10 |
| Decision Date | 2012-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867661000318 | K122443 | 000 |