The following data is part of a premarket notification filed by Visicu, Inc. with the FDA for Ecaremanager 4.1.
| Device ID | K171322 |
| 510k Number | K171322 |
| Device Name: | ECareManager 4.1 |
| Classification | System, Network And Communication, Physiological Monitors |
| 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 | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-05 |
| Decision Date | 2017-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838099807 | K171322 | 000 |
| 00884838101050 | K171322 | 000 |
| 00884838102910 | K171322 | 000 |
| 00884838087453 | K171322 | 000 |