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510(k) K854374

OXYGEN CONCENTRATOR, MODEL BX-5000 by Healthdyne, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1986
Date Received
October 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

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