FDA.reportPublic FDA data

ANZAI MEDICAL CO, LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80315573008328959ANZAI MEDICAL CO, LTD.1N2027-01-012-6-9 OHSAKI SHINAGAWA-KU Tokyo JP 141-0023

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
109001848349225K170719Anzai Respiratory Gating SystemLHN2017-04-05
109001196393486K160432Anzai Respiratory Gating SystemLHN2016-04-22
109001993769890K031385ANZAI AZ-733 RESPIRATORY GATING SYSTEMLHN2003-11-10
109001395403722
109001431620965

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LHN32017-04-05

PMN#