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510(k) K070609

APEX MEDICAL XT1 CPAP, MODEL 9S-005 by Apex Medical Corp. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2007
Date Received
March 5, 2007
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

Other clearances by Apex Medical Corp.

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  • K150111 — Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series (September 15, 2015)
  • 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)

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