Contact Information
For more information about our products, please visit www.
gurinproducts
.com.
This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) this device may not cause harmful interference, and (2)
this device must accept any interference received, including interference that may
cause undesired operation.
FCC Statement
Complied Standards List
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements and
Clinical investigation
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of
risk management to medical devices
ISO/EN 15223-1:2012 Medical devices. Symbols to
be used with medical device labels, labelling and
information to be supplied. General requirements
IEC 60601-1: 2005+A1
：
2012 Medical electrical
equipment - Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-11 Medical electrical equipment - Part
1-11: General requirements for basic safety and essential
performance - Collateral standard: Requirements for
medical electrical equipment and medical electrical
systems used in the home healthcare environment
IEC/EN 60601-1-2:2007 Medical electrical equipment -
Part 1-2: General requirements for basic safety and
essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests
IEC 80601-2-30:2009 Medical electrical equipment-
Part 2-30: Particular requirements for the basic safety
and essential performance of automated non-invasive
sphygmomanometers
IEC/EN 62304:2006+AC: 2008 Medical device
software - Software life cycle processes
Usability
IEC 62366 Medical devices - Application of usability
engineering to medical devices (IEC 62366:2007)
IEC 60601-1-6 Medical electrical equipment - Part 1 -
6: General requirements for basic safety and essential
performance - collateral standard : Usability
ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic,
or automated sphygmomanometers
EN 1041:2008 Information supplied by the manufacturer
of medical devices
Distributed By: Gurin Products LLC
2522 Chambers Road, Suite 100 Tustin, CA-92780 USA
Questions/Warranty: [email protected]
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CONTACT INFORMATION
COMPLIED STANDARDS LIST
