Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Exercise Equipment

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

July 25, 1995

Last updated

March 17, 2020

Description

A guidance document for preparing premarket notification applications for exercise equipment, focusing on premarket requirements.

Organization

Country / Region

United States

License

Other (Public Domain)

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