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510(k) K952694

CO BREATH ANALYSIS MODULE & MONOXOL II by Bacharach, Inc. — Product Code CCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1996
Date Received
June 14, 1995
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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