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510(k) K060461

V-505 INFA WARMER by Atom Medical, Inc. — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2006
Date Received
February 22, 2006
Clearance Type
Special
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, Inc.

  • K061856 — V-2200 INFANT INCUBATOR (September 28, 2006)
  • K061071 — V-808 ATOM TRANSCAPSULE (August 29, 2006)
  • K021809 — V-2100G ADVANCED INFANT INCUBATOR (July 18, 2002)
  • K002355 — ATOM INFA WARMER V-505 (October 10, 2000)

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