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510(k) K103523

185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX by International Biomedical, Ltd. — Product Code FPL

K103523 is an FDA 510(k) premarket notification submitted by International Biomedical, Ltd. for the device "185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX". The FDA issued a decision of Substantially Equivalent on May 11, 2011. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. International Biomedical, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2011
Date Received
December 1, 2010
Clearance Type
Special
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, Ltd.

  • 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)
  • 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)
  • 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)

Other clearances for product code FPL

  • K220742 — NxtGen Infant Transport Incubator (July 15, 2022)
  • K161918 — SREE MRI Transport Incubator (March 3, 2017)
  • K141565 — GLOBE-TROTTER GT5400 (September 10, 2014)
  • K123937 — ATOM TRANSCAPSULE V-707 (May 23, 2013)
  • 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)

FDA data resources