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510(k) K102649

NEOPOP INFANT RESUSCITATOR WITH FLOW METER by Neoforce Group, Inc. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2011
Date Received
September 14, 2010
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 Neoforce Group, Inc.

  • K110119 — PRESSURE MANOMETER (June 10, 2011)
  • K103833 — NEOPIP PATIENT CIRCUIT WITH PEEP (April 20, 2011)
  • K092085 — ISPIRA RESUSCITATION UNIT (October 7, 2009)
  • K072021 — NEOPIP INFANT RESUSCITATOR (September 12, 2007)
  • K070416 — NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP (May 29, 2007)
  • K061280 — V-2200 INFANT INCUBATOR (June 27, 2006)

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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)
  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (January 13, 2012)