FDA.reportPublic FDA data

Device Listing 1768635636

Listing Summary#

Listing key
1768635636
Premarket submission
K190805
Device
PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL
Applicant
Pentax of America, Inc.
Product code
PEA
Decision date
2019-12-20