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510(k) K041828

APEX MEDICAL CPAP MODEL 9S-003 by Apex Medical Corp. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2004
Date Received
July 7, 2004
Clearance Type
Special
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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