The following data is part of a premarket notification filed by Visicu, Inc. with the FDA for Ecare Coordinator (ecc).
| Device ID | K141706 |
| 510k Number | K141706 |
| Device Name: | ECARE COORDINATOR (ECC) |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | VISICU, INC. 217 E. REDWOOD ST., STE. 1900 Baltimore, MD 21202 |
| Contact | Chris Ferguson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-06-24 |
| Decision Date | 2014-09-09 |
| Summary: | summary |