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510(k) K021809

V-2100G ADVANCED INFANT INCUBATOR by Atom Medical Corp — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2002
Date Received
June 3, 2002
Clearance Type
Abbreviated
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 Corp

  • K061856 — V-2200 INFANT INCUBATOR (September 28, 2006)
  • K061071 — V-808 ATOM TRANSCAPSULE (August 29, 2006)
  • K060461 — V-505 INFA WARMER (April 28, 2006)
  • K002355 — ATOM INFA WARMER V-505 (October 10, 2000)

Other clearances for product code FMZ

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  • K243437 — mOm Essential Incubator (ME1) (August 14, 2025)
  • K213553 — Giraffe Incubator Carestation CS1 (March 2, 2022)
  • K190494 — Infant Incubator (November 25, 2019)
  • K182859 — Babyleo TN500 (February 22, 2019)
  • K182977 — Isolette 8000 Plus (November 21, 2018)
  • K172154 — Isolette 8000 plus (April 19, 2018)
  • K162821 — Babyleo TN500 (June 23, 2017)
  • K152814 — Giraffe OmniBed Carestation CS1 (March 17, 2016)