Graham Field 14423-4, 14423-2, 14423-8 user manual Appendix A, EC Declaration of Conformity

10 APPENDIX A, EC DECLARATION OF CONFORMITY

EC Declaration of Conformity

Manufactured for	GF Health Products, Inc., 2935 Northeast Parkway,
	Atlanta, GA 30360
Product	Ultrasound Pocket Doppler
Classification	(MDD, Annex IX): IIa

We herewith declare that the above mentioned product(s) meet the transposition into national law, the provisions of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices - as amended by Directive 98/79/EC on in vitro diagnostic medical devices.

All supporting documentation is retained at the premises of the manufacturer.

Directives	General Applicable Directives: Medical Device
	Directive: COUNCIL DIRECTIVE 93/42/EEC of 14
	June 1993 concerning medical devices (MDD 93/42/
	EEC).
Standards applied	EN ISO 9001, ISO13485, EN ISO14971, EN ISO10993-
	1, IEC 601-1, EN 60601-1-1, BS EN 60601-1-4, IEC
	60601-1-2, EN 61157, EN 1041, EN 60417-2-2000,
	IEC/TR 60878-2003, EN 980, EN 55011, ISO 1000, YY
	0111-93, EN 61266, EN ISO 780 , GB/T 14740, GB/T
	15464
Notified Body	TÜV SÜD Product Service GmbH, Ridlerstr 65, D-
	80339 MÜnchen, Germany.
Identification
number

14423-INS-LAB-RevD11 35