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510(k) K253939

DeltaWave Nasal Pillow System by RemSleep Holdings, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2026
Date Received
December 9, 2025
Clearance Type
Special
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

Other clearances by RemSleep Holdings, Inc.

  • K233415 — DELTAWAVE Nasal Pillows System (July 2, 2024)

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