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510(k) K972193

OLYMPIX MINI-PASTEURMATIC (58210) by Olympic Medical Corp. — Product Code LDS

K972193 is an FDA 510(k) premarket notification submitted by Olympic Medical Corp. for the device "OLYMPIX MINI-PASTEURMATIC (58210)". The FDA issued a decision of Substantially Equivalent on September 5, 1997. The device falls under product code LDS (Device, Pasteurization, Hot Water), a Class II device regulated under 21 CFR 880.6991. Olympic Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1997
Date Received
June 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Pasteurization, Hot Water
Device Class
Class II
Regulation Number
880.6991
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)
  • K971117 — WARMETTE (August 22, 1997)
  • K955357 — OLYMPIC SMART SCALE MODEL 50/50RA (January 30, 1996)
  • K954434 — OLYMPIC INFANT THERMOMETER (December 20, 1995)
  • K955177 — OLYMPIC SMART SCALE (December 14, 1995)

Other clearances for product code LDS

  • K183444 — Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer- (September 9, 2019)
  • K031799 — MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 (November 12, 2003)
  • K983068 — RELIANCE FAMILY OF WASHER-DISINFECTORS (May 31, 2000)
  • K950518 — MIELE G 7781 DENTAL THERMAL DISINFECTOR (January 26, 1996)
  • K950566 — DECOMAT 4656 (October 19, 1995)
  • K953645 — OLYMPIC PASTEURMATIC SYSTEM (September 22, 1995)
  • K884151 — MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. (May 16, 1989)
  • K860263 — CASTLE 7538 FLOOR LOADING WASHER (March 5, 1986)
  • K844089 — CASTLE 7515 UTENSIL/GLASSWARE WASHER (January 14, 1985)
  • K810311 — STERI-VERS (April 17, 1981)

FDA data resources