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510(k) K931529

INFANT WARMER by Medix I.C.S.A. — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1994
Date Received
March 26, 1993
Clearance Type
Traditional
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 Medix I.C.S.A.

  • K103735 — MEDILED MINI (August 15, 2011)
  • K083179 — MEDILED PHOTOTHERAPY LAMP (February 27, 2009)
  • K070291 — MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX (September 21, 2007)
  • K931965 — MEDIX PHOTOTHERAPY LAMP (December 9, 1993)
  • K920049 — MEDIX PC-305 NEONATAL INCUBATOR (May 21, 1993)

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