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510(k) K922623

NEBULIZER SYSTEM by Healthdyne, Inc. — Product Code BTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1992
Date Received
June 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type

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