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

Related Registrations

Registration keyRegistrationFEICompanyStatusInitial importerExpirationAddress
8564225188971000080301PENTAX of America, Inc.1Y2026-01-013 Paragon Drive MONTVALE NJ US 07645
1049096108773008185830Paresh Patel1N2026-01-013 Paragon Drive Montvale NJ US 07645
1048930037826063003782606William Goeller1N2020-04-253 Paragon Drive Montvale NJ US 07645
1048830037826103003782610HOYA Corporation PENTAX Lifecare Division1N2026-01-0130-2 Okada, Aza-Shimomiyano, Tsukidate KURIHARA-SHI Miyagi JP 987-2203
27453430146052023014605202PENTAX MEDICAL (PENANG) SDN. BHD.1N2026-01-01Plot 554, Lorong Perusahaan 4 Prai Free Trade Zone Penang Pulau Pinang MY 13600