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510(k) K904286

SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED by Scale-Tronix, Inc. — Product Code FRW

K904286 is an FDA 510(k) premarket notification submitted by Scale-Tronix, Inc. for the device "SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED". The FDA issued a decision of Substantially Equivalent on October 1, 1990. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Scale-Tronix, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1990
Date Received
August 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scale, Patient
Device Class
Class I
Regulation Number
880.2720
Review Panel
HO
Submission Type

Other clearances by Scale-Tronix, Inc.

  • K935609 — 4002 INFANT SCALE FOR INCUBATORS AND WARMERS (July 1, 1994)
  • K912662 — SCALE-TRONIX PLATFORM SCALE (March 27, 1992)
  • K902260 — SCALE-TRONIX INCUBATOR SCALE MODEL:4050 (August 14, 1990)

Other clearances for product code FRW

  • K955357 — OLYMPIC SMART SCALE MODEL 50/50RA (January 30, 1996)
  • K954846 — OLYMPIC SMART SCALE (December 14, 1995)
  • K955177 — OLYMPIC SMART SCALE (December 14, 1995)
  • K952649 — WARM-SCALE (August 15, 1995)
  • K943587 — ADVANCED IN-BED WEIGH SYSTEM (September 22, 1994)
  • K932572 — DIGITAL BABY SCALE MODEL BLB-12 (November 16, 1993)
  • K926174 — MODEL 9100 H.R. INFANT SCALE (October 25, 1993)
  • K926446 — EZ PUMP (September 27, 1993)
  • K926058 — 3M MODEL 280RT RATE TAPER INFUSION PUMP (August 16, 1993)
  • K926059 — 3M MODEL 200RT RATE TAPER INFUSION PUMP (August 16, 1993)

FDA data resources