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510(k) K940951

RW RESUCITAIRE INFANT RADIANT WARMER by Air-Shields, Inc. — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1995
Date Received
March 2, 1994
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

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  • K922150 — EXAMINATION LAMP (July 21, 1992)
  • K914864 — MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR (March 13, 1992)

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