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510(k) K001019

TI500 GLOBE-TROTTER TRANSPORT SYSTEM by Hill-Rom Air-Shields — Product Code FPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2000
Date Received
March 30, 2000
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 Hill-Rom Air-Shields

  • K021622 — HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 (April 1, 2003)
  • K003335 — RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL (November 17, 2000)
  • K001242 — ISOLETTE INFANT INCUBATOR, MODEL C2HS (July 13, 2000)
  • K993051 — VERSALET 7700 CARE CENTER, MODEL # 7700 (February 3, 2000)

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)
  • K103523 — 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ 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)