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510(k) K233855

AllPEP by Enchant Tek Co. , Ltd. — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2024
Date Received
December 5, 2023
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

Other clearances by Enchant Tek Co. , Ltd.

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