510(k) K142932
K142932 is an FDA 510(k) premarket notification submitted by Deltex Medical Limited for the device "Deltex Medical KDP72 Doppler Probe". The FDA issued a decision of Substantially Equivalent on January 22, 2015. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Deltex Medical Limited has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2015
- Date Received
- October 9, 2014
- 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