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510(k) K935609

4002 INFANT SCALE FOR INCUBATORS AND WARMERS by Scale-Tronix, Inc. — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1994
Date Received
November 19, 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 Scale-Tronix, Inc.

  • K912662 — SCALE-TRONIX PLATFORM SCALE (March 27, 1992)
  • K904286 — SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED (October 1, 1990)
  • K902260 — SCALE-TRONIX INCUBATOR SCALE MODEL:4050 (August 14, 1990)

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