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Welch Allyn Schiller SP-1 - Product Overview and Compliance; Declaration of Conformity

Welch Allyn Schiller SP-1
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DECLARATION
OF
CONFORMITY
Spirometer:
SP-1
Serial
numbers
starting
with:
540.
Year
of
manufacture:
1995
Onwards
We,
the
undersigned,
hereby
declare
that
the
medical
device
(class
Ila)
specified
above
conforms
with
the
essential
requirement
listed
in
Annex
1
of
EC
Directive
93/42/EEC.
This
declaration
is
supported
by:
Certificate
of
approval
No:
11425-01
ISO
9001
(Rev.
1994)
EN
46001
by
SQS
45112-60-00
ISO
9001/08.94,
EN
46001
/
12.93
by
DEKRA
and
45112-16-00
Annex
II,
Section
3
of
the
Directive
93/42/
EEC
(30.04.1995)
0124
Baar
(Switzerland)
03.07.1996
Martin
Sprang
Markus
Butler
Research
&
Development
Manager
Quality
Assurance
Manager

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