Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices

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 heating and cooling devices.

Organization

Country / Region

United States

License

Other (Public Domain)

Feedback

Suggest an improvement to this page

Actions

Social networks

Embed