510(k) K181248
K181248 is an FDA 510(k) premarket notification submitted by Comarch Healthcare SA for the device "Comarch e-Care Platform". The FDA issued a decision of Substantially Equivalent on Oct 22, 2018. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 22, 2018
- Date Received
- May 10, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 870.2910
- Review Panel
- CV
- Submission Type
- 510(k)