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510(k) K120035

APEX MEDICAL ICH CPAP SERIES (9S-007XXX) by Apex Medical Corp. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2012
Date Received
January 4, 2012
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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  • K141522 — APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES (October 6, 2014)
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  • K103174 — APEX MEDICAL WIZARD SERIES CPAP MASK (May 6, 2011)
  • K103535 — VACPLUS SUCTION UNIT (February 24, 2011)
  • K083656 — APEX MEDICAL XT AUTO CPAP 9S-005200 (April 22, 2009)

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