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510(k) K110383

BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 by A Plus Medical — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2011
Date Received
February 10, 2011
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 A Plus Medical

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  • K110471 — BABI PLUS INFANT NASAL CANNULA SYSTEM (October 7, 2011)
  • K102377 — VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 (November 18, 2010)
  • K093716 — BABI PLUS INFANT NASAL CANNULA SYSTEM (May 13, 2010)
  • K092687 — VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER (November 23, 2009)
  • K090317 — BABI*PLUS BUBBLE PAP VALVE (May 20, 2009)

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