510(k) K896718
K896718 is an FDA 510(k) premarket notification submitted by Bicore Monitoring Systems for the device "BICORE VARIFLEX(R) FLOW TRANSDUCER". The FDA issued a decision of Substantially Equivalent on February 22, 1990. The device falls under product code BYR (Transducer, Gas Pressure, Differential), a Class I device regulated under 21 CFR 868.2875. Bicore Monitoring Systems has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 1990
- Date Received
- November 29, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Gas Pressure, Differential
- Device Class
- Class I
- Regulation Number
- 868.2875
- Review Panel
- AN
- Submission Type