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De Novo DK800699

Device
Blood And Plasma Warming Devices
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
DK800699
510(k) number
DEVICECLASSIFICATIONUNDERSECTION513F2DENOVOQUICKLINKSSKIPTOMAINPAGECONTENTSKIPTOSEARCHSKIPTOTOPICSMENUSKIPTOCOMMONLIN
Product code
KZL  
Regulation
864.9205
Classification name
Device, Warming. Blood And Plasma
Decision
Substantially Equivalent (SE)
Decision date
1980-05-08
Date received
1980-04-28
Classification advisory
Hematology
Review advisory
Hematology
Type
510(k) Traditional