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510(k) K234134

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System by Resmed Pty Ltd (Registration Number: 3004604967) — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2024
Date Received
December 29, 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

Other clearances by Resmed Pty Ltd (Registration Number: 3004604967)

  • K230476 — Oran Park Mask (October 19, 2023)
  • K223747 — Whitsundays Mask System (July 6, 2023)

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