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510(k) K112783

MANUJET III by VBM Medizintechnik GmbH — Product Code BTL

K112783 is an FDA 510(k) premarket notification submitted by VBM Medizintechnik GmbH for the device "MANUJET III". The FDA issued a decision of Substantially Equivalent on December 22, 2011. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. VBM Medizintechnik GmbH has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2011
Date Received
September 26, 2011
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 VBM Medizintechnik GmbH

  • K200190 — ScalpelCric (October 30, 2020)
  • K955461 — TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). (March 19, 1997)

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