Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Whitsundays Mask System

K-Number: K223747 · 2023-07-06

ApplicantResmed Pty Ltd (Registration Number: 3004604967)
Decision Date2023-07-06
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Whitsundays Mask System is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Pty Ltd (Registration Number: 3004604967). It received FDA 510(k) clearance on 2023-07-06 under 510(k) number K223747. 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 Whitsundays Mask System?

Whitsundays Mask System is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is Resmed Pty Ltd (Registration Number: 3004604967). The 510(k) number is K223747.

When did Whitsundays Mask System receive FDA 510(k) clearance?

Whitsundays Mask System received FDA 510(k) clearance on 2023-07-06, under 510(k) number K223747.

Who is the listed applicant for Whitsundays Mask System?

The FDA 510(k) record lists Resmed Pty Ltd (Registration Number: 3004604967) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Whitsundays Mask System?

The FDA product code for Whitsundays Mask System is BZD.

Other records listing Resmed Pty Ltd (Registration Number: 3004604967) 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.

K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask SystemK230476Oran Park Mask

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.

↑