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510(k) K912662

SCALE-TRONIX PLATFORM SCALE by Scale-Tronix, Inc. — Product Code FRW

K912662 is an FDA 510(k) premarket notification submitted by Scale-Tronix, Inc. for the device "SCALE-TRONIX PLATFORM SCALE". The FDA issued a decision of Substantially Equivalent on March 27, 1992. 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
March 27, 1992
Date Received
June 18, 1991
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)
  • K904286 — SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED (October 1, 1990)
  • 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