ECARE COORDINATOR (ECC)— 510(k) K141706
Substantially EquivalentVisicu, Inc.
FDA 510(k) clearance K141706 for ECARE COORDINATOR (ECC), Substantially Equivalent on 2014-09-09. Applicant: Visicu, Inc.. Device class: 2.
Clearance details
- Applicant
- Visicu, Inc.
- Product code
- Code DRG
- Device class
- Class 2
- Regulation
- 21 CFR 870.2910
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baltimore, MD, US
Recent devices under product code DRG
view allMore clearances from Visicu, Inc.
view allAdverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K141706
K-number listed on FDA's recall record- Z-1708-2017 — eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCare Coordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients.
- Z-1557-2016 — eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141706.
Data sourced from openFDA. This site is unofficial and independent of the FDA.