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510(k) K002355

ATOM INFA WARMER V-505 by Atom Medical Corp — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2000
Date Received
August 2, 2000
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Infant Radiant
Device Class
Class II
Regulation Number
880.5130
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)
  • K021809 — V-2100G ADVANCED INFANT INCUBATOR (July 18, 2002)

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