510(k) K141706
K141706 is an FDA 510(k) premarket notification submitted by Visicu, Inc. for the device "ECARE COORDINATOR (ECC)". The FDA issued a decision of Substantially Equivalent on September 9, 2014. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Visicu, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2014
- Date Received
- June 24, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 870.2910
- Review Panel
- CV
- Submission Type