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510(k) K150639

AF541 EE Full Face Mask by Respironics, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2015
Date Received
March 11, 2015
Clearance Type
Abbreviated
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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Other clearances for product code BZD

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  • K243023 — WiZARD 520 Full Face Mask (May 23, 2025)
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  • K242935 — Respiration Data Management Software (PAP Link PC) (January 15, 2025)
  • K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-0 (December 31, 2024)