Home / 510(k) Clearances / K182956

510(k) K182956

Puffin Lite Infant Resuscitation System by International Biomedical — Product Code BTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2019
Date Received
October 24, 2018
Clearance Type
Special
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 International Biomedical

  • K221154 — Infant Heel WarmerTM; Heel Snuggler® (October 7, 2022)
  • K221653 — InfaTherm Disposable Infant Warming Mattress (October 6, 2022)
  • K220742 — NxtGen Infant Transport Incubator (July 15, 2022)
  • K193481 — AeroNOx 2.0 Nitric Oxide Titration & Monitoring System (March 10, 2020)
  • K173516 — NuBorne Infant Warmer (August 17, 2018)
  • K160238 — Airborne Phototherapy Light (June 14, 2016)
  • K140707 — LIFEBORNE INFANT RESUSCITATOR (May 28, 2014)
  • K103525 — A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NE (May 11, 2011)
  • K103523 — 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NE (May 11, 2011)
  • K103524 — VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WIT (April 15, 2011)

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)
  • 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)
  • K140049 — MOVES SLC (May 29, 2014)