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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Remsleep Holdings. It received FDA 510(k) clearance on 2024-07-02 under 510(k) 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. The listed applicant is Remsleep Holdings. The 510(k) number is K233415.

When did DELTAWAVE Nasal Pillows System receive FDA 510(k) clearance?

DELTAWAVE Nasal Pillows System received FDA 510(k) clearance on 2024-07-02, under 510(k) number K233415.

Who is the listed applicant for DELTAWAVE Nasal Pillows System?

The FDA 510(k) record lists Remsleep Holdings as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DELTAWAVE Nasal Pillows System?

The FDA product code for DELTAWAVE Nasal Pillows System is BZD.

Other records listing Remsleep Holdings as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253939DeltaWave Nasal Pillow System

Related Devices (Code: BZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

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.

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