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510(k) K920812

FAIRBANKS BABY SCALE by Fairbanks Scales, Inc. — Product Code FRW

K920812 is an FDA 510(k) premarket notification submitted by Fairbanks Scales, Inc. for the device "FAIRBANKS BABY SCALE". The FDA issued a decision of Substantially Equivalent on May 13, 1992. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1992
Date Received
February 21, 1992
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 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