Home / 510(k) Clearances / K233555

510(k) K233555

AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask by Philips Respironics — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2024
Date Received
November 6, 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 Philips Respironics

  • K111378 — OXIMETRY INTERFACE KIT (October 4, 2011)

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