Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff

Name: Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: 510k,clarifications,diathermy,fda,guidances,industry,notification,policies,pre-market,pre-market-notification,submissions,ultrasonic

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

February 21, 2023

Last updated

February 21, 2023

Description

This document is a guidance for industry and FDA staff on policy clarification and premarket notification for ultrasonic diathermy devices.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff

Updated on February 21, 2023

pdf (545.4KB)

URL: https://www.fda.gov/media/107094/download
Permalink: https://data.openrid.co/en/datasets/r/7f987d6e-0cf4-4e58-a27c-4890ede5d0a1
MIME Type: application/pdf

Created on: February 21, 2023
Modified on: February 21, 2023

Size: 545.4KB

Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Country / Region

License

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