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510(k) K090317

BABI*PLUS BUBBLE PAP VALVE by A Plus Medical — Product Code BYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2009
Date Received
February 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Device Class
Class II
Regulation Number
868.5965
Review Panel
AN
Submission Type

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  • 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)

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  • K081266 — MERCURY MEDICAL PEEP VALVE (March 5, 2009)