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510(k) K243513

DCM (PW-DCM) by Pneumowave, Ltd. — Product Code LEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2025
Date Received
November 12, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sleep Assessment
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

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