Embla Sandman - Declaration of Conformity; Caution for the U.S. Market

SD32+ System Safety
2.3. declaration of conformity
The SD32+ amplifier meets the requirements of Annex II of the 93/42/EEC Directive on Medical
Devices (MDD). For these reasons, the equipment is marked with the CE mark. IMQ S.p.A.
(Milan, Italy) issues the approval as the Notified Body notified by the European Commission. The
IMQ notified body identifier number is 0051.
The equipment is marked with the cCSAus quality mark. This safety mark is valid for both
Canadian and U.S. markets.
2.4. caution for the U.S. market
Federal law restricts this device to sale by or on the order of a physician.
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