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510(k) K932572

DIGITAL BABY SCALE MODEL BLB-12 by Tanita Corp. of America — Product Code FRW

K932572 is an FDA 510(k) premarket notification submitted by Tanita Corp. of America for the device "DIGITAL BABY SCALE MODEL BLB-12". The FDA issued a decision of Substantially Equivalent on November 16, 1993. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Tanita Corp. of America has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1993
Date Received
May 27, 1993
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 Tanita Corp. of America

  • K040778 — TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) (December 23, 2004)
  • K040978 — TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE (July 22, 2004)
  • K033157 — TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418 (April 8, 2004)
  • K014009 — TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE (June 24, 2002)
  • K930599 — BODY FAT ANALYZER MODEL TBF-105 (November 1, 1994)

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)
  • 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)
  • K930626 — SANITAS PATIENT SCALE (August 6, 1993)

FDA data resources