FDA.reportPublic FDA data

SHAPE MEDICAL SYSTEMS, INC

Matched from indexed company URL: Shape Medical Systems, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30080729323008072932SHAPE MEDICAL SYSTEMS, INC1N2026-01-01MedTech Center/Shape Medical Systems, In 5000 Township Parkway Saint Paul MN US 55110

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1060861628612535K150888Shape-HF Cardiopulmonary Testing SystemBTY2016-01-21
1060861664252575K090722SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEMBTY2009-03-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BTY22016-01-21

PMN#

GUDID#