K171322 is an FDA 510(k) clearance for the eCareManager 4.1. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).
Submitted by Visicu, Inc. (Baltimore, US). The FDA issued a Cleared decision on August 3, 2017, 90 days after receiving the submission on May 5, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K171322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2017 |
| Decision Date | August 03, 2017 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MSX - System, Network And Communication, Physiological Monitors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |