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LTRDESCRIPTIONDATE (RHODA)APPROVED120208C. Baffled device type 02 tested at low dose rate. Make changes to paragraph
1.2.2, 1.5, 4.4.1c, 4.4.4.1, Table I and figure 1. roared
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What is add device type 02?
Add device type 02 refers to a specific classification used to report newly added devices in regulatory documentation.
Who is required to file add device type 02?
Manufacturers and distributors of medical devices that are introducing new devices or modifications to existing devices are required to file add device type 02.
How to fill out add device type 02?
To fill out add device type 02, include device identification information, regulatory classifications, and any relevant testing data as required by the regulatory authority.
What is the purpose of add device type 02?
The purpose of add device type 02 is to ensure that regulatory bodies are informed of new devices or changes to existing devices, thereby maintaining safety and compliance.
What information must be reported on add device type 02?
Information that must be reported includes device name, model number, manufacturing details, intended use, and any applicable regulatory references.
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