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510(k) K013027

MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 by Respironics Healthscan, Inc. — Product Code BTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2001
Date Received
September 10, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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