510(k) K896718

BICORE VARIFLEX(R) FLOW TRANSDUCER by Bicore Monitoring Systems — Product Code BYR

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