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510(k) K253166

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) by BMC Medical Co., Ltd. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2026
Date Received
September 26, 2025
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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