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510(k) K161918

SREE MRI Transport Incubator by Advanced Imaging Research Dba Sree Medical Systems — Product Code FPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2017
Date Received
July 13, 2016
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 Advanced Imaging Research Dba Sree Medical Systems

  • K113365 — INFANT ARRAY (March 29, 2012)

Other clearances for product code FPL

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  • 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)
  • K062052 — LMT NOMAG IC 3.0 (July 31, 2006)