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510(k) K041823

PIONEER U121 SERIES CPAP by Merits Health Products Co., Ltd. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2005
Date Received
July 6, 2004
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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