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510(k) K150111

Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series by Apex Medical Corp. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2015
Date Received
January 20, 2015
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

Other clearances by Apex Medical Corp.

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  • K193206 — WiZARD 510 Nasal Mask (October 29, 2020)
  • K182394 — WiZARD 310/320 Series CPAP Mask (May 17, 2019)
  • K141522 — APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES (October 6, 2014)
  • K121642 — WIZARD 230 NASAL PILOW MASK (June 6, 2013)
  • K112079 — APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 (December 6, 2012)
  • K120035 — APEX MEDICAL ICH CPAP SERIES (9S-007XXX) (May 16, 2012)
  • 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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