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510(k) K112852

BABI PLUS NEONATAL RESUSCITATION BAG by A Plus Medical — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2012
Date Received
October 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

Other clearances by A Plus Medical

  • K110471 — BABI PLUS INFANT NASAL CANNULA SYSTEM (October 7, 2011)
  • K110383 — BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 (August 1, 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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  • K210288 — Disposable Manual Resuscitator (August 26, 2021)
  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun (May 11, 2018)
  • K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR (August 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K102824 — AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC (January 28, 2011)