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510(k) K083656

APEX MEDICAL XT AUTO CPAP 9S-005200 by Apex Medical Corp. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2009
Date Received
December 10, 2008
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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  • K103535 — VACPLUS SUCTION UNIT (February 24, 2011)

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