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510(k) K902113

VITALOGRAPH - BREATHCO MONITOR by Mcneill Intl., Inc. — Product Code CCJ

K902113 is an FDA 510(k) premarket notification submitted by Mcneill Intl., Inc. for the device "VITALOGRAPH - BREATHCO MONITOR". The FDA issued a decision of Substantially Equivalent on October 26, 1990. 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 26, 1990
Date Received
May 11, 1990
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