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510(k) K123937

ATOM TRANSCAPSULE V-707 by Atom Medical Corporation — Product Code FPL

K123937 is an FDA 510(k) premarket notification submitted by Atom Medical Corporation for the device "ATOM TRANSCAPSULE V-707". The FDA issued a decision of Substantially Equivalent on May 23, 2013. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. Atom Medical Corporation has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2013
Date Received
December 20, 2012
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 Atom Medical Corporation

  • K120937 — SUNFLOWER WARNER (July 6, 2012)
  • K111547 — BILI-THERAPY PAD TYPE (April 12, 2012)
  • K103317 — RESUSCITATION UNIT 105 (April 20, 2011)
  • K102542 — RESUSCI FLOW; RESUSCI FLOW 104 (April 6, 2011)
  • K103828 — BILI-THERAPY SPOT TYPE (March 29, 2011)
  • K102227 — INFA WARMER I (January 21, 2011)
  • K102226 — DUAL INCU I (January 4, 2011)
  • K102279 — INCU I (December 29, 2010)
  • K102710 — NEO-SERVO I (December 22, 2010)

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

FDA data resources