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510(k) K062052

LMT NOMAG IC 3.0 by Lmt Lammers Medical Technology GmbH — Product Code FPL

K062052 is an FDA 510(k) premarket notification submitted by Lmt Lammers Medical Technology GmbH for the device "LMT NOMAG IC 3.0". The FDA issued a decision of Substantially Equivalent on July 31, 2006. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. Lmt Lammers Medical Technology GmbH has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2006
Date Received
July 20, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Incubator, Neonatal Transport
Device Class
Class II
Regulation Number
880.5410
Review Panel
HO
Submission Type

Other clearances by Lmt Lammers Medical Technology GmbH

  • K033565 — LMT NOMAG IC 1,5 (November 21, 2003)

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