Visicu, Inc.
FDA Regulatory Profile
Visicu, Inc. appears in FDA public data with 1 recall, 7 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0399-2016, Class II) was initiated on March 27, 2015. Its most recent 510(k) clearance was granted on June 3, 2022.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0399-2016 | Class II | The eCareManager system. Software intended for use in data collection, storage and clinical informa | March 27, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211046 | eCareManager 4.5 | June 3, 2022 |
| K171322 | eCareManager 4.1 | August 3, 2017 |
| K171029 | eCareCoordinator | July 14, 2017 |
| K153156 | eCareManager 4.0.1 | September 30, 2016 |
| K141706 | ECARE COORDINATOR (ECC) | September 9, 2014 |
| K012171 | MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS | July 24, 2001 |
| K001972 | ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK | October 27, 2000 |