DELTAWAVE Nasal Pillows System
K-Number: K233415 · 2024-07-02
ApplicantRemsleep Holdings
Decision Date2024-07-02
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
DELTAWAVE Nasal Pillows System is a medical device manufactured by Remsleep Holdings. It received FDA 510(k) clearance on 2024-07-02 under approval number K233415. 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 Pillows System?
DELTAWAVE Nasal Pillows System is a medical device that received FDA 510(k) clearance on 2024-07-02. It is manufactured by Remsleep Holdings. The 510(k) number is K233415.
When was DELTAWAVE Nasal Pillows System approved by the FDA?
DELTAWAVE Nasal Pillows System received FDA 510(k) clearance on 2024-07-02, under approval number K233415.
What company makes DELTAWAVE Nasal Pillows System?
DELTAWAVE Nasal Pillows System is manufactured by Remsleep Holdings.
What is the FDA product code for DELTAWAVE Nasal Pillows System?
The FDA product code for DELTAWAVE Nasal Pillows 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.