510(k) K180479
K180479 is an FDA 510(k) premarket notification submitted by Sensible Medical Innovations , Ltd. for the device "ReDS System". The FDA issued a decision of Substantially Equivalent on February 28, 2019. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Sensible Medical Innovations , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2019
- Date Received
- February 22, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- CV
- Submission Type