eCareCoordinator
FDA 510(k) K171029 · Visicu, Inc.
510(k) numberK171029
Submission
- Device name
- eCareCoordinator
- Applicant
- Visicu, Inc.
Baltimore, MD, US - Received
- April 6, 2017
- Decision date
- July 14, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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More from Cardioline S.P.A
| 510(k) | Device | Decision |
|---|---|---|
| K211046 | eCareManager 4.5MSX · Traditional | 06/03/2022SE |
| K171322 | eCareManager 4.1MSX · Traditional | 08/03/2017SE |
| K153156 | eCareManager 4.0.1MSX · Traditional | 09/30/2016SE |
| 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 eCareCoordinator cleared by the FDA?
eCareCoordinator (K171029) received a 510(k) decision of Substantially Equivalent on July 14, 2017, 99 days after the submission was received.
What is the product code of K171029?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.