The following data is part of a premarket notification filed by Visicu, Inc. with the FDA for Ecaremanager 4.0.1.
| Device ID | K153156 |
| 510k Number | K153156 |
| Device Name: | ECareManager 4.0.1 |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | VISICU, INC. 217 E. REDWOOD ST., STE. 1900 Baltimore, MD 21202 |
| Contact | Daniel R. Plonski |
| Correspondent | Daniel R. Plonski VISICU, INC. 217 E. REDWOOD ST., STE. 1900 Baltimore, MD 21202 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-02 |
| Decision Date | 2016-09-30 |
| Summary: | summary |