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510(k) K081094

OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 by Olympic Medical Corp. — Product Code MEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2008
Date Received
April 17, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Disinfector, Medical Devices
Device Class
Class II
Regulation Number
880.6992
Review Panel
HO
Submission Type

Other clearances by Olympic Medical Corp.

  • 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)
  • K954846 — OLYMPIC SMART SCALE (December 14, 1995)

Other clearances for product code MEC

  • K911120 — DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21 (February 3, 1994)