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510(k) K020797

PULMO-MIST COMPRESSOR MODEL # 4323 by Nidek Medical Products, Inc. — Product Code BTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2002
Date Received
March 12, 2002
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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