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510(k) K921717

BICORE SMARTVALVE OCCLUSION VALVE by Bicore Monitoring Systems — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1992
Date Received
April 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type

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  • K896718 — BICORE VARIFLEX(R) FLOW TRANSDUCER (February 22, 1990)

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