510(k) K133903
K133903 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "BIO-PROBE TRANSDUCER (ADULT)". The FDA issued a decision of Substantially Equivalent on April 10, 2014. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Medtronic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2014
- Date Received
- December 20, 2013
- 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