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510(k) K252338

MySleepDash by Somnetics International, Inc. (Dba Transcend Inc) — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2026
Date Received
July 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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