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510(k) K831028

TI-1000 TRANSPORT INCUBATOR by Narco Scientific — Product Code FPL

K831028 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "TI-1000 TRANSPORT INCUBATOR". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. Narco Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1983
Date Received
March 30, 1983
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 Narco Scientific

  • K830338 — NARCOTRACE 80 (December 22, 1983)
  • K831428 — AS 1740 INTERFACE MODULE (October 14, 1983)
  • K831429 — AS 191 ECG TELEMETRY MODULE (October 14, 1983)
  • K822835 — PZ-800 VOLUME VENTILATOR (September 29, 1983)
  • K831430 — AIR SHIELDS AS-100 MONIORING SYS-AS105 (September 12, 1983)
  • K831460 — AS 30/TCP MODULE (July 12, 1983)
  • K830123 — DISP. YANKAVER SURG. SUCTION INSTRUMENT (June 8, 1983)
  • K823899 — INFANT CARE SYSTEM (April 14, 1983)
  • K830680 — AIR-SHIELDS VENTIMETER VENTILATOR-CONTR (April 8, 1983)
  • K830654 — INFUSION PUMP RETROGRADE EXTEN. AS 715 (March 24, 1983)

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)
  • K103524 — VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WIT (April 15, 2011)
  • K103527 — AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WIT (April 15, 2011)
  • K081399 — AVIATOR TRANSPORT INCUBATOR (June 6, 2008)
  • K061071 — V-808 ATOM TRANSCAPSULE (August 29, 2006)

FDA data resources