The following data is part of a premarket notification filed by Etiometry, Inc. with the FDA for T3 Software.
Device ID | K142732 |
510k Number | K142732 |
Device Name: | T3 Software |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
Applicant | Etiometry, Inc. 119 Braintree Street Boston, MA 02134 |
Contact | Dimitar Baronov |
Correspondent | Pamela J. Weagraff Quintiles Consulting 18 Bridie Lane Norfolk, MA 02056 |
Product Code | MWI |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-23 |
Decision Date | 2015-03-04 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
T3 SOFTWARE 78136408 2750376 Dead/Cancelled |
PJH Scopists, LLC 2002-06-17 |