510(k) K010482
K010482 is an FDA 510(k) premarket notification submitted by Echocath, Inc. for the device "ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1". The FDA issued a decision of Substantially Equivalent on March 20, 2001. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880. Echocath, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2001
- Date Received
- February 20, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 870.2880
- Review Panel
- CV
- Submission Type