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510(k) K150173

Aerobika OPEP Devive with Manometer by Trudell Medical International — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2015
Date Received
January 26, 2015
Clearance Type
Special
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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