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510(k) K133873

TRIBALL INCENTIVE SPIROMETER by Besmed Health Business Corp — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2014
Date Received
December 20, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

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