T3 Software
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
ETIOMETRY, INC.
The following data is part of a premarket notification filed by Etiometry, Inc. with the FDA for T3 Software.
Pre-market Notification Details
| Device ID | K163065 |
| 510k Number | K163065 |
| Device Name: | T3 Software |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | ETIOMETRY, INC. 119 BRAINTREE STREET SUITE 210 Boston, MA 02134 |
| Contact | Dimitar Baronov |
| Correspondent | Richard E. Galgon QUINTILES 5846 COBBLESTONE LANE Waunakee, WI 53597 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-02 |
| Decision Date | 2017-05-26 |
| Summary: | summary |
Trademark Results [T3 Software]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T3 SOFTWARE 78136408 2750376 Dead/Cancelled |
PJH Scopists, LLC 2002-06-17 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.