natus XLTEK EEG32 User Manual

XLTEK EEG32U Amplifier User and Service Manual
22
Description of Symbols
Symbol Standard Reference
Standard Title
of Symbol
Symbol Title
as per
Referenced
Standard
Explanation
ISO 15223-1
Symbol 5.7.7
Medical devices
— Symbols to be
used with
information to
be supplied by
the
manufacturer —
Part 1: General
requirements
An indication
of Medical
Device
This product is a
medical device.
Medical Device
Directive 93/42/EEC
or
Medical Device
Regulation 2017/745
as applicable
Council Directive
93/42/EEC
Regulation (EU)
2017/745
CE Marking of
Conformity
Signifies European
technical
conformity.
Notified body
number appears
under symbol if
applicable.
ISO 15223-1
Symbol 5.1.2
Medical devices
— Symbols to be
used with
information to
be supplied by
the
manufacturer —
Part 1: General
requirements
Authorized
representative
in the
European
Community
Indicates the
Authorized
representative in
the European
Community.
UK MDR 2002
UKCA Mark
UKCA Mark
Signifies Great
Britain (England,
Wales, and
Scotland)
conformity.
UK Approved Body
number appears
under symbol.
Swiss Medical Device
Ordinance (MedDO)
Swiss Authorized
Representative
Swiss
authorized
representative
Indicates the
Authorized
representative in
Switzerland.
21 CFR 801.109(b)(1)
Labeling-
Prescription
devices
Device is
cleared for the
US market as
requiring a
prescription
Indicates that the
product is
authorized for sale
by or on the order
of a licensed
healthcare
practitioner.

natus XLTEK EEG32 Specifications

General

Brand	natus
Model	XLTEK EEG32
Category	Medical Equipment
Language	English