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Product
Disclosure ( 2001 - 2011 )
LIFE SUPPORT
AND AUTOMOBILE APPLICATION POLICY
LIFE SUPPORT
POLICY:
OSCILENT
CORPORATION'S PRODUCTS ARE NOT AUTHORIZED FOR USE AS CRITICAL
COMPONENTS IN LIFE SUPPORT DEVICES AND SYSTEMS WITHOUT THE
EXPRESS WRITTEN APPROVAL OF THE PRESIDENT OF OSCILENT CORPORATION.
AUTOMOBILE
APPLICATION POLICY:
OSCILENT
CORPORATION'S PRODUCTS ARE NOT AUTHORIZED FOR USE AS LIFE
CRITICAL COMPONENTS IN AUTOMOBILE APPLICATIONS AND SYSTEMS
WITHOUT THE EXPRESS WRITTEN APPROVAL OF THE PRESIDENT OF OSCILENT
CORPORATION
As used
herein for Life Support and Automobile Application Policies:
1. Life
support devices or systems are devices or systems which, (a)
are intended for surgical implant into the body, or (b) support
or sustain life, and (c) whose failure to perform when properly
used in accordance with instructions for use provided in the
labeling, can be reasonably expected to result in a significant
injury or death to the user.
2. A critical
component in any component of a life support device or system
whose failure to perform can be reasonably expected to cause
the failure of the life support device or system, or to affect
its safety or effectiveness.
3.Automobile
applications and systems are devices or systems which, (a)
are intended to prevent bodily harm in the event of accident,
or (b) make up any portion or element of a safety system,
and (c) whose failure to perform when properly used in accordance
with instructions for use provided in the labeling, can be
reasonably expected to result in a significant injury or death
to the user.
4. A critical
component in any component of an automobile application, device,
or system whose failure to perform can be reasonably expected
to cause the failure of the automobile device or system, or
to affect its safety or effectiveness in any way.
Oscilent
Corporation
18226 McDurmott Street
Building B
Irvine . CA . 92614 . USA
Tel:
949.252.0522
Fax: 949.252.0599
Email: info@oscilent.com
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