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510(k) K022650

APEX MEDICAL CPAP RT 21XX by Apex Medical Corp. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2004
Date Received
August 9, 2002
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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