DeltaWave Nasal Pillow System
K-Number: K253939 · 2026-01-07
ApplicantRemSleep Holdings, Inc.
Decision Date2026-01-07
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
DeltaWave Nasal Pillow System is a medical device manufactured by RemSleep Holdings, Inc.. It received FDA 510(k) clearance on 2026-01-07 under approval number K253939. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DeltaWave Nasal Pillow System?
DeltaWave Nasal Pillow System is a medical device that received FDA 510(k) clearance on 2026-01-07. It is manufactured by RemSleep Holdings, Inc.. The 510(k) number is K253939.
When was DeltaWave Nasal Pillow System approved by the FDA?
DeltaWave Nasal Pillow System received FDA 510(k) clearance on 2026-01-07, under approval number K253939.
What company makes DeltaWave Nasal Pillow System?
DeltaWave Nasal Pillow System is manufactured by RemSleep Holdings, Inc..
What is the FDA product code for DeltaWave Nasal Pillow System?
The FDA product code for DeltaWave Nasal Pillow System is BZD.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.