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510(k) K102279

INCU I by Atom Medical Corporation — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2010
Date Received
August 11, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal
Device Class
Class II
Regulation Number
880.5400
Review Panel
HO
Submission Type

Other clearances by Atom Medical Corporation

  • K123937 — ATOM TRANSCAPSULE V-707 (May 23, 2013)
  • 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)
  • K102710 — NEO-SERVO I (December 22, 2010)

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  • K213553 — Giraffe Incubator Carestation CS1 (March 2, 2022)
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  • K172154 — Isolette 8000 plus (April 19, 2018)
  • K162821 — Babyleo TN500 (June 23, 2017)
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