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510(k) K092085

ISPIRA RESUSCITATION UNIT by Neoforce Group, Inc. — Product Code BTL

K092085 is an FDA 510(k) premarket notification submitted by Neoforce Group, Inc. for the device "ISPIRA RESUSCITATION UNIT". The FDA issued a decision of Substantially Equivalent on October 7, 2009. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. Neoforce Group, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2009
Date Received
July 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
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)
  • K102649 — NEOPOP INFANT RESUSCITATOR WITH FLOW METER (January 6, 2011)
  • 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)

Other clearances for product code BTL

  • K242769 — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (April 4, 2025)
  • K221634 — Oxymag - Transport and Emergency Ventilator (May 24, 2023)
  • K202219 — VORTRAN GO2VENT with PEEP Valve (February 11, 2021)
  • K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (November 20, 2020)
  • K182956 — Puffin Lite Infant Resuscitation System (January 18, 2019)
  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K161420 — MOVES SLC (June 6, 2017)
  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K141595 — O-TWO E700,O-TWO E600,O-TWO E500 (March 16, 2015)
  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)

FDA data resources