The following data is part of a premarket notification filed by Visicu, Inc. with the FDA for Ecaremanager 4.5.
| Device ID | K211046 |
| 510k Number | K211046 |
| Device Name: | ECareManager 4.5 |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | Visicu, Inc. 217 East Redwood Street Baltimore, MD 21202 |
| Contact | Janine Treter |
| Correspondent | Janine Treter Visicu, Inc. 217 East Redwood Street 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 | 2021-04-08 |
| Decision Date | 2022-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838106963 | K211046 | 000 |
| 00884838115460 | K211046 | 000 |
| 00884838121249 | K211046 | 000 |