510(k) K142503
K142503 is an FDA 510(k) premarket notification submitted by Intersection Medical, Inc. for the device "IMED-Z FLUID STATUS MONITOR". The FDA issued a decision of Substantially Equivalent on June 5, 2015. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2015
- Date Received
- September 5, 2014
- 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