The following data is part of a premarket notification filed by Bicore Monitoring Systems with the FDA for Bicore Variflex(r) Flow Transducer.
Device ID | K896718 |
510k Number | K896718 |
Device Name: | BICORE VARIFLEX(R) FLOW TRANSDUCER |
Classification | Transducer, Gas Pressure, Differential |
Applicant | BICORE MONITORING SYSTEMS 2 FARADAY Irvine, CA 92718 |
Contact | David B Viele |
Correspondent | David B Viele BICORE MONITORING SYSTEMS 2 FARADAY Irvine, CA 92718 |
Product Code | BYR |
CFR Regulation Number | 868.2875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-29 |
Decision Date | 1990-02-22 |