The following data is part of a premarket notification filed by Visicu Inc. with the FDA for Ecarecoordinator.
Device ID | K171029 |
510k Number | K171029 |
Device Name: | ECareCoordinator |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | Visicu Inc. 217 East Redwood St. Suite 1900 Baltimore, MD 21202 |
Contact | Daniel R. Plonski |
Correspondent | Milind Gramopadhye Visicu Inc. 217 East Redwood St. Suite 1900 Baltimore, MD 21202 |
Product Code | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-06 |
Decision Date | 2017-07-14 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ECARECOORDINATOR 79176204 5051807 Live/Registered |
Koninklijke Philips N.V. 2015-08-14 |
ECARECOORDINATOR 76254066 not registered Dead/Abandoned |
I-trax Health Management Solutions, Inc. 2001-05-08 |