<script type="text/javascript">
<!--
document.write('<div id="oa_widget"></div>');
document.write('<script type="text/javascript" src="https://www.openaire.eu/index.php?option=com_openaire&view=widget&format=raw&projectId=undefined&type=result"></script>');
-->
</script>

COPY SCRIPT

For further information contact us at helpdesk@openaire.eu

What's in a 510(k)?

Name: What's in a 510(k)?
Creator: R. Munzner
Keywords: 0206 medical engineering, 02 engineering and technology, 3. Good health

descriptionPublicationkeyboard_double_arrow_right Article 01 May 2003 English Publisher:Institute of Electrical and Electronics Engineers (IEEE)Journal:IEEE Engineering in Medicine and Biology Magazine, volume 22, pages 157-158 (issn: 0739-5175,

Authors: R. Munzner;

doi: 10.1109/memb.2003.1213643

What's in a 510(k)?

- Summary
- Metrics

Abstract

If you hope to market a new medical device in the United States, sending a premarket notification, or 510(k) is probably the easiest and fastest way to do so. The article briefly looks at the 510(k) and outlines what it is, gives guidelines for preparing it including useful resources, and gives an idea of fees and review time required.

Impact byBIP!

	citations This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).	1
	popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.	Average
	influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).	Average
	impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.	Average