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Accession Number
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AVA16114-VNB1
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Title
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Medical Device Regulations: Premarket Notification - The 510(k) Process.
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Publication Date
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1994
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Media Count
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1AV-VHS 1/2 inch - 1 cassette
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Personal Author
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N/A
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Abstract
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This program describes the premarket notification, known as the 510(k) process. 510(k) is the mechanism through which new medical devices are screened by the FDA before they may be placed on the market. This program discusses 510(k) thoroughly including w ...
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Keywords
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510(k) process
Administrative procedures
Diagnostic equipment
Medical devices
Medical equipment
Notification procedures
Prosthetic equipment
Regulations
Reviewing
US FDA
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Source Agency
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Office of Communication Media Center for Devices and Radiological Health - FDA - Audiovisual
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NTIS Subject Category
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95A - Prosthetics & Mechanical Organs
95C - Biomedical Instrumentation & Bioengineering
92D - Education, Law, & Humanities
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Corporate Author
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Food and Drug Administration, Rockville, MD. Office of Communication Media Center for Devices and Radiological Health.
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Document Type
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Audiovisual
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Title Note
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N/A
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NTIS Issue Number
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0003
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Contract Number
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N/A
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