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510(k) K230476

Oran Park Mask by Resmed Pty Ltd (Registration Number: 3004604967) — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2023
Date Received
February 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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