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510(k) K954846

OLYMPIC SMART SCALE by Olympic Medical Corp. — Product Code FRW

K954846 is an FDA 510(k) premarket notification submitted by Olympic Medical Corp. for the device "OLYMPIC SMART SCALE". The FDA issued a decision of Substantially Equivalent on December 14, 1995. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Olympic Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1995
Date Received
October 23, 1995
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 Olympic Medical Corp.

  • K081094 — OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 (June 20, 2008)
  • K031149 — OLYMPIC CFM 6000 (May 14, 2003)
  • K020335 — OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 (June 18, 2002)
  • K001056 — OLYMPIC WARM-UP (September 29, 2000)
  • K983229 — OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM (March 23, 1999)
  • K971601 — OLYMPIC BILI-BASSINET (September 24, 1997)
  • K972193 — OLYMPIX MINI-PASTEURMATIC (58210) (September 5, 1997)
  • K971117 — WARMETTE (August 22, 1997)
  • K955357 — OLYMPIC SMART SCALE MODEL 50/50RA (January 30, 1996)
  • K954434 — OLYMPIC INFANT THERMOMETER (December 20, 1995)

Other clearances for product code FRW

  • K955357 — OLYMPIC SMART SCALE MODEL 50/50RA (January 30, 1996)
  • 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)
  • K930626 — SANITAS PATIENT SCALE (August 6, 1993)

FDA data resources