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510(k) K021809

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

K021809 is an FDA 510(k) premarket notification submitted by Atom Medical Corp for the device "V-2100G ADVANCED INFANT INCUBATOR". The FDA issued a decision of Substantially Equivalent on July 18, 2002. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Atom Medical Corp has at least 4 other 510(k) clearances on record.

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

  • K251619 — Babyleo TN500 (February 13, 2026)
  • K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (October 22, 2025)
  • 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)

FDA data resources