CANAMET’s Piesometer Mk-1, a non-invasive blood pressure (NIBP) monitoring
system, has obtained the Canadian Medical Device Licence (License Number 67375)
on February 15, 2005.
Earlier on January 21, 2005, CSA International has issued the Certificate of
Compliance (Certificate Number: 227083) for the Piesometer Mk-1. The system has
met CSA’s Canadian and U.S. Electrical Safety Code and international recognized
safety requirements for medical device (IEC 60601). With this certification, the
Piesometer Mk-1 is allowed to bear the CSA (Canada-U.S.) Mark.
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With the FDA 510(k) clearance (K041169) and CANAMET’s U.S. establishment
registration (Registration Number: 3004793673) obtained in Year 2004, the
Piesometer Mk-1 is now ready to enter fully into the North American Market. The
CE Mark submission for the European market is in progress, it is expected that
the Piesometer Mk-1 will obtain the CE Mark and ready for the European Market
entry in April 2005.
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