Home / 510(k) Clearances / K220742

510(k) K220742

NxtGen Infant Transport Incubator by International Biomedical — Product Code FPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2022
Date Received
March 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal Transport
Device Class
Class II
Regulation Number
880.5410
Review Panel
HO
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)
  • K193481 — AeroNOx 2.0 Nitric Oxide Titration & Monitoring System (March 10, 2020)
  • K182956 — Puffin Lite Infant Resuscitation System (January 18, 2019)
  • K173516 — NuBorne Infant Warmer (August 17, 2018)
  • K160238 — Airborne Phototherapy Light (June 14, 2016)
  • K140707 — LIFEBORNE INFANT RESUSCITATOR (May 28, 2014)
  • K103523 — 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NE (May 11, 2011)
  • K103525 — A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I 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 FPL

  • K161918 — SREE MRI Transport Incubator (March 3, 2017)
  • K141565 — GLOBE-TROTTER GT5400 (September 10, 2014)
  • K123937 — ATOM TRANSCAPSULE V-707 (May 23, 2013)
  • K103523 — 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NE (May 11, 2011)
  • K103525 — A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NE (May 11, 2011)
  • K103527 — AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WIT (April 15, 2011)
  • K103524 — VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WIT (April 15, 2011)
  • K081399 — AVIATOR TRANSPORT INCUBATOR (June 6, 2008)
  • K061071 — V-808 ATOM TRANSCAPSULE (August 29, 2006)
  • K062052 — LMT NOMAG IC 3.0 (July 31, 2006)