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510(k) K934930

OLYMPIC AUTO-LENGTH by Olympic Medical Corp. — Product Code FTY

K934930 is an FDA 510(k) premarket notification submitted by Olympic Medical Corp. for the device "OLYMPIC AUTO-LENGTH". The FDA issued a decision of Substantially Equivalent on December 29, 1993. The device falls under product code FTY (Tape, Measuring, Rulers And Calipers), a Class I device regulated under 21 CFR 878.4800. Olympic Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1993
Date Received
October 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape, Measuring, Rulers And Calipers
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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 FTY

  • K160501 — Noxilizer Surgical Ruler (May 26, 2016)
  • K951064 — DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC (May 19, 1995)
  • K932112 — OLYMPIC INFA-LENGTH (July 22, 1993)
  • K883485 — STRYKER PRESSURE MONITOR SYSTEM (September 13, 1988)
  • K880441 — PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. (February 18, 1988)
  • K874352 — TUMORIMETER (November 23, 1987)
  • K873470 — TEMPLATE (September 8, 1987)
  • K872319 — LN 100 BREAST MARKER (August 11, 1987)
  • K863409 — KUNDIN WOUND GAUGE (September 29, 1986)
  • K862576 — PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) (July 15, 1986)

FDA data resources