For what it's worth, the Sphygmocor Xcel took 4 months to get clearance and was designated class II when submitted 10 years ago.
I'm guessing the Pulse will be the same (class II) and they'll be going for the substantially equivalent per below as with the Sphygmocor submission.
Given the backlog at the FDA we shouldn't be too surprised we've ticked over 5 months now.
For what it's worth, the Sphygmocor Xcel took 4 months to get...
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Last
5.2¢ |
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-0.002(3.70%) |
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| Open | High | Low | Value | Volume |
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Change
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