Premarket Notifications (510(k)s)

Metadata Updated: November 10, 2020

Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Summaries of safety and effectiveness information is available via the web interface for more recent records.

Access & Use Information

Public: This dataset is intended for public access and use. License: See this page for license information.

Downloads & Resources

Dates

Metadata Created Date November 10, 2020
Metadata Updated Date November 10, 2020

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date November 10, 2020
Metadata Updated Date November 10, 2020
Publisher Department of Health & Human Services
Unique Identifier Unknown
Maintainer
Identifier 13c32f66-2252-4b5c-a7eb-2f00eaede130
Data First Published 2014-01-09
Data Last Modified 2016-09-02
Public Access Level public
Bureau Code 009:10
Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
Metadata Catalog ID https://healthdata.gov/data.json
Schema Version https://project-open-data.cio.gov/v1.1/schema
Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
Homepage URL https://healthdata.gov/dataset/premarket-notifications-510ks
License https://opendatacommons.org/licenses/odbl/1.0/
Program Code 009:005
Source Datajson Identifier True
Source Hash 50291d7b29821f913ba0b23f77d2bea69b2c896a
Source Schema Version 1.1

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