De Novo DK820583

Device

Unclassified

Requester

Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Fo

Requester address

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Contact

Device Classification Under Section 513(f)(2)(de N

De Novo number

DK820583

510(k) number

DEVICECLASSIFICATIONUNDERSECTION513F2DENOVOQUICKLINKSSKIPTOMAINPAGECONTENTSKIPTOSEARCHSKIPTOTOPICSMENUSKIPTOCOMMONLIN

Product code

ZZZ

Regulation

Device Classification Under Section 513(f)(2)(de N

Classification name

Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food &amp; Drug Administration &nbsp; Follow FDA En Espa&ntilde;ol Search FDA &nbsp; Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood &amp; Biologics Animal &amp; Veterinary Cosmetics Tobacco Products &nbsp; Device Classification Under Section 513(f)(2)(de Novo) Var MP = { Version: '1.0.22', Domains: {'es':'esp.fd

Decision

Substantially Equivalent (SE)

Decision date

1982-11-29

Date received

1982-09-29

Classification advisory

Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food &amp; Drug Administration &nbsp; Follow FDA En Espa&ntilde;ol Search FDA &nbsp; Home Fo

Review advisory

Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food &amp; Drug Administration &nbsp; Follow FDA En Espa&ntilde;ol Search FDA &nbsp; Home Fo

Type

510(k) Traditional