510(k) K052989
K052989 is an FDA 510(k) premarket notification submitted by Deltex Medical for the device "DP240 240 HOUR DOPPLER PROBE". The FDA issued a decision of Substantially Equivalent on March 8, 2006. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Deltex Medical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2006
- Date Received
- October 24, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Blood-Flow, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2120
- Review Panel
- CV
- Submission Type