eCareManager 4.0.1
FDA 510(k) K153156 · Visicu, Inc.
510(k) numberK153156
Submission
- Device name
- eCareManager 4.0.1
- Applicant
- Visicu, Inc.
Baltimore, MD, US - Received
- November 2, 2015
- Decision date
- September 30, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K261287 | Digistat CareMSX · Traditional | Ascom Ums Srl Unipersonale | 09/12/2026SE |
| K260211 | Dashboard (P007000)MSX · Traditional | Hill-Rom, Inc. | 08/13/2026SE |
| K261367 | Corsano CardioWatch 287-2 SystemMSX · Traditional | Corsano Health B.V. | 07/26/2026SE |
| K253654 | IntelliVue Measurement Rack 6000 (867317)MSX · Traditional | Philips Medizin Systeme Böblingen GmbH | 03/30/2026SE |
| K243270 | TigerConnect Alarm ManagementMSX · Traditional | Tigerconnect | 09/30/2025SE |
| K242728 | BeneVision Central Monitoring SystemMSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/31/2025SE |
| K242750 | Central StationMSX · Traditional | Nihon Kohden Digital Health Solutions, LLC | 06/05/2025SE |
| K242842 | ANNE View, Central HubMSX · Traditional | Sibel Health, Inc. | 01/08/2025SE |
| K241397 | HinscopeMSX · Traditional | Hinlab Sas | 11/14/2024SE |
| K233834 | Infinity Gateway SuiteMSX · Traditional | Draeger Medical Systems, Inc. | 07/12/2024SE |
More from Draeger Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K211046 | eCareManager 4.5MSX · Traditional | 06/03/2022SE |
| K171322 | eCareManager 4.1MSX · Traditional | 08/03/2017SE |
| K171029 | eCareCoordinatorDRG · Traditional | 07/14/2017SE |
| K141706 | Ecare Coordinator (Ecc)DRG · Traditional | 09/09/2014SE |
| K012171 | Modification to: Argus System-Continuous Expert Care Network W/Smart AlramsMSX · Special | 07/24/2001SE |
| K001972 | Argus System-Continuous Expert Care NetworkMSX · Traditional | 10/27/2000SE |
Questions and answers
When was eCareManager 4.0.1 cleared by the FDA?
eCareManager 4.0.1 (K153156) received a 510(k) decision of Substantially Equivalent on September 30, 2016, 333 days after the submission was received.
What is the product code of K153156?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.