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510(k) K892841

BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR by Bedfont Technical Instruments , Ltd. — Product Code CCJ

K892841 is an FDA 510(k) premarket notification submitted by Bedfont Technical Instruments , Ltd. for the device "BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR". The FDA issued a decision of Substantially Equivalent on October 5, 1989. The device falls under product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1430.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1989
Date Received
April 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1430
Review Panel
AN
Submission Type

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FDA data resources