510(k) K850657
K850657 is an FDA 510(k) premarket notification submitted by Flowtronics, Inc. for the device "THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR". The FDA issued a decision of Substantially Equivalent on February 22, 1985. The device falls under product code LME (Monitor, Blood-Flow, Cerebral, Thermal Diffusion), a Class III device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 1985
- Date Received
- January 28, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Blood-Flow, Cerebral, Thermal Diffusion
- Device Class
- Class III
- Regulation Number
- Review Panel
- NE
- Submission Type