The following data is part of a premarket notification filed by Telemed Solutions, Inc. with the FDA for Tm Ecloud Ecg Analysis System.
Device ID | K142349 |
510k Number | K142349 |
Device Name: | TM ECloud ECG Analysis System |
Classification | Computer, Diagnostic, Programmable |
Applicant | Telemed Solutions, Inc. 6251 Schaefer Avenue, Suite K Chino, CA 91710 |
Contact | Ken Burns |
Correspondent | Ken Burns Telemed Solutions, Inc. 6251 Schaefer Avenue, Suite K Chino, CA 91710 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-22 |
Decision Date | 2015-09-21 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TM ECLOUD ECG ANALYSIS SYSTEM 86804526 5020822 Live/Registered |
Telemed Solutions 2015-10-30 |