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K13 09 19JUlL 0 2 2013 510(k) Summary for NeuroMetrix SENSUSTM SPONSORNeuroMetrix, Inc. 62 Fourth Avenue Waltham, MA 02451 USA Contact Person: Telephone: Date Prepared:Rainer Maas (781) 3142781 March
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How to fill out k140586 tradedevice name ascend
How to fill out k140586 tradedevice name ascend
01
Gather all necessary documentation for the K140586 trade device.
02
Start filling out the form by entering the device's name as 'Ascend'.
03
Ensure you enter the correct identification numbers associated with the device.
04
Provide details about the manufacturer and model number.
05
Fill in the specifications and features of the device.
06
Review all entries for accuracy and completeness.
07
Submit the completed form through the appropriate channel.
Who needs k140586 tradedevice name ascend?
01
Manufacturers looking to register their medical device with regulatory bodies.
02
Healthcare providers needing to acquire the K140586 trade device for use.
03
Regulatory agencies that require information on medical devices for compliance.
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What is k140586 tradedevice name ascend?
The k140586 is a specific FDA regulation that pertains to a medical device named 'Ascend'.
Who is required to file k140586 tradedevice name ascend?
Manufacturers or importers of the device 'Ascend' are required to file the k140586.
How to fill out k140586 tradedevice name ascend?
To fill out the k140586, the filer should provide product details, manufacturer information, and comply with all FDA submission guidelines.
What is the purpose of k140586 tradedevice name ascend?
The purpose of the k140586 is to ensure that the 'Ascend' device meets safety and effectiveness standards before it can be marketed.
What information must be reported on k140586 tradedevice name ascend?
Information to be reported includes device description, intended use, detailed labeling, and any clinical or non-clinical data that supports its safety and effectiveness.
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