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510(k) K895791

OXYMAX by Columbus Instruments Intl. Corp. — Product Code BZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1990
Date Received
September 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Oxygen-Uptake
Device Class
Class II
Regulation Number
868.1730
Review Panel
AN
Submission Type

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