Company ยท US
Visicu, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2022. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 2022 | K211046 | eCareManager 4.5 Visicu, Inc. | MSX |
| Aug 3, 2017 | K171322 | eCareManager 4.1 Visicu, Inc. | MSX |
| Jul 14, 2017 | K171029 | eCareCoordinator Visicu, Inc. | DRG |
| Sep 30, 2016 | K153156 | eCareManager 4.0.1 Visicu, Inc. | MSX |
| Sep 9, 2014 | K141706 | ECARE COORDINATOR (ECC) Visicu, Inc. | DRG |
| Jul 24, 2001 | K012171 | MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS Visicu, Inc. | MSX |
| Oct 27, 2000 | K001972 | ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK Visicu, Inc. | MSX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2015 | Visicu, Inc. The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either di Terminated |
MSX | K001972 K012171 |
| Apr 27, 2012 | Visicu, Inc. Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8.
Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinica Terminated |
MSX | K001972 K012171 |