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510(k) K031096

MODIFICATION TO TRANSPORT INCUBATOR 185 by International Biomedics, Inc. — Product Code FPL

K031096 is an FDA 510(k) premarket notification submitted by International Biomedics, Inc. for the device "MODIFICATION TO TRANSPORT INCUBATOR 185". The FDA issued a decision of Substantially Equivalent on June 24, 2003. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. International Biomedics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2003
Date Received
April 7, 2003
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 Biomedics, Inc.

  • K860933 — AIR-CUSHION TOCOTONOMETER (July 9, 1986)
  • K862072 — FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01 (July 9, 1986)
  • K860295 — FETASCAN 1500 (May 19, 1986)
  • K852439 — FETA SCAN 1000 OBSTETRICAL IMAGER (August 30, 1985)

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)
  • 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)

FDA data resources