510(k) K161408
K161408 is an FDA 510(k) premarket notification submitted by Centurion Medical Products Corporation for the device "Compass Cast and MAP". The FDA issued a decision of Substantially Equivalent on November 22, 2016. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Centurion Medical Products Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2016
- Date Received
- May 20, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Blood-Pressure, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2850
- Review Panel
- CV
- Submission Type