Regulatory
Certifications
Company
On January 4, 2006, CardioDynamics International Corporation received certification to ISO 13485:2003 from Nemko AS. A Certificate of Conformity with European Directive was issued on January 20, 2006 from Nemko AS. Finally, the Canadian Medical Devices Conformity Assessment System Certificate (CMDCAS) from DQS GmbH was issued on March 2, 2006. These certifications are the most widely recognized international standards for developing, manufacturing, and servicing medical devices.
| BioZ® Dx |
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CE Mark (0470) - Received January 4, 2006. The CE Mark allows CardioDynamics to ship and sell the BioZ throughout the European Community.
FDA Approval - Received FDA 510(k) clearance on December 6, 2004. FDA approval allows the company to legally market the device throughout the United States.
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| BioZ® Monitor |
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CE Mark (0470) - Received January 4, 2006. The CE Mark allows CardioDynamics to ship and sell the BioZ throughout the European Community.
FDA Approval - Received FDA 510(k) clearance on March 18, 1998. FDA approval allows the company to legally market the device throughout the United States. |
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| BioZ ICG Module® |
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CE Mark
Solar 7000 & 8000 - Received June 2001
Solar 8000M - Received February 2002
Dash - pending
The CE Mark allows GE Medical Systems - Information Technologies
to ship and sell the BioZ ICG Module throughout the European
Community.
FDA Approval
Solar 7000 & 8000 - Received
June 2001
Solar 8000M - Received February 2002
Dash - Received April 2002
FDA 510(k) clearance approval allows the
company to legally market the device throughout the United States.
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