Olympic Pasteurmatic, Models 3000 and 3500

• • Terminated Z-2701-2017 FDA Class II ·initiated 22 May 2017

  Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the Olympic Pasteurmatic 3000/3500 System devices by means of disabling the devices.

510(k) Number

K081094 ↗

FDA Product Code

MEC

Device Class

Class II

Regulation

21 CFR Part 880.6992

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Olympic Smart Scale Care Center

  Class II

  FDA 510(k) K920423 Active Cleared 11 Jun 1992

• Olympic Medical Lectromed Cerebral Function Monitor System, Model 5330

  Class II

  FDA 510(k) K020335 Active Cleared 18 Jun 2002

• Lube-Lok

  Class I

  FDA 510(k) K781695 Active Cleared 1 Nov 1978

• Olympic Bili-Lite-Pad(Tm)

  Class II

  FDA 510(k) K901987 Active Cleared 16 Jul 1990

• Olympix Mini-Pasteurmatic (58210)

  Class II

  FDA 510(k) K972193 Active Cleared 5 Sep 1997

• Warm-Scale

  Class I

  FDA 510(k) K952649 Active Cleared 15 Aug 1995

See all devices from Olympic Medical Corp. →