510(k) K063111
K063111 is an FDA 510(k) premarket notification submitted by Finapres Medical Systems B.V. for the device "FINOMETER MODEL-2 WITH ACCESSORIES". The FDA issued a decision of Substantially Equivalent on Feb 1, 2007. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Finapres Medical Systems B.V. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 1, 2007
- Date Received
- Oct 11, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type
- 510(k)