Premarket Notifications (510(k)s)

Metadata Updated: February 26, 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 June 19, 2015
Metadata Updated Date February 26, 2020

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date June 19, 2015
Metadata Updated Date February 26, 2020
Publisher Department of Health & Human Services
Unique Identifier e5246333-c717-48aa-933b-d136514aca6e
Maintainer
admin
Maintainer Email
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
Harvest Object Id 82feb5dd-ec45-4d1a-9895-c1625139d060
Harvest Source Id 15c538b5-31a0-474e-8ba5-c85ee421cb4d
Harvest Source Title Healthdata.gov
Data First Published 2015-03-31
Homepage URL https://healthdata.gov/dataset/premarket-notifications-510ks-0
License https://opendatacommons.org/licenses/odbl/1.0/
Data Last Modified 2016-04-05
Program Code 009:005
Source Datajson Identifier True
Source Hash 1e3c74fd9454fb4a53475f4db9260ec162094ebd
Source Schema Version 1.1

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