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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K230476
Device Name Oran Park Mask
Applicant
Resmed Pty Ltd (Registration Number: 3004604967)
1 Elizabeth Macarthur Dr.
Bella Vista,  AU 2153
Applicant Contact Daniellia Chan
Correspondent
Resmed Corp (Registration Number: 3007573469)
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Correspondent Contact Sheila Bruschi
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/22/2023
Decision Date 10/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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