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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number:
k153286
B. Purpose for Submission:
Modified devices to add compatibility with
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How to fill out modified devices to add
01
Access the settings menu on the modified device.
02
Look for the 'Add Devices' option in the settings.
03
Select the 'Add Devices' option to initiate the process.
04
Follow the on-screen prompts to specify the type of device you want to add.
05
Provide the necessary information such as device name, model number, and any other required details.
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Once all the required information is filled out, click on the 'Add' button to complete the process.
Who needs modified devices to add?
01
Individuals who have modified their devices and wish to expand their functionality by adding additional devices.
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What is modified devices to add?
Modified devices to add refer to any changes made to existing devices to enhance their functionality or features.
Who is required to file modified devices to add?
Manufacturers or distributors of the modified devices are required to file the necessary documentation.
How to fill out modified devices to add?
The modified devices to add form can be filled out online through the designated regulatory website.
What is the purpose of modified devices to add?
The purpose of filing modified devices to add is to ensure regulatory compliance and transparency in the marketplace.
What information must be reported on modified devices to add?
Information such as the nature of the modification, testing results, and intended use of the modified devices must be reported.
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