The following data is part of a premarket notification filed by United States Gtm Medical Devices, Inc. with the FDA for Tl-300 T-line Non-invasive Blood Pressure Monitoring System.
| Device ID | K123446 |
| 510k Number | K123446 |
| Device Name: | TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | United States GTM Medical Devices, Inc. 5850 Oberlin Drive #240 San Diego, CA 92121 |
| Contact | Kenneth K Kleinhenz |
| Correspondent | Kenneth K. Kleinhenz United States GTM Medical Devices, Inc. 5850 Oberlin Drive #240 San Diego, CA 92121 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-08 |
| Decision Date | 2012-12-07 |