The following data is part of a premarket notification filed by Etiometry, Inc. with the FDA for T3 Software.
Device ID | K152258 |
510k Number | K152258 |
Device Name: | T3 Software |
Classification | Multivariate Vital Signs Index |
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 | PLB |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-11 |
Decision Date | 2016-03-31 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
T3 SOFTWARE 78136408 2750376 Dead/Cancelled |
PJH Scopists, LLC 2002-06-17 |