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510(k) K220565

Hudson RCI Triflo II Incentive Deep Breathing Exerciser by Medline Industries, Inc. — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2022
Date Received
February 28, 2022
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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