Ecare Coordinator (Ecc)
FDA 510(k) K141706 · Visicu, Inc.
510(k) numberK141706
Submission
- Device name
- Ecare Coordinator (Ecc)
- Applicant
- Visicu, Inc.
Baltimore, MD, US - Received
- June 24, 2014
- Decision date
- September 9, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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
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|---|---|---|
| K211046 | eCareManager 4.5MSX · Traditional | 06/03/2022SE |
| K171322 | eCareManager 4.1MSX · Traditional | 08/03/2017SE |
| K171029 | eCareCoordinatorDRG · Traditional | 07/14/2017SE |
| K153156 | eCareManager 4.0.1MSX · Traditional | 09/30/2016SE |
| 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 Ecare Coordinator (Ecc) cleared by the FDA?
Ecare Coordinator (Ecc) (K141706) received a 510(k) decision of Substantially Equivalent on September 9, 2014, 77 days after the submission was received.
What is the product code of K141706?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.