FDA.reportPublic FDA data

ZOE MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30032946443003294644ZOE MEDICAL, INC.1N2026-01-01460 BOSTON ST. TOPSFIELD MA US 01983

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
575341585008829K150620740 SELECTMWI2015-05-08
575341803481862K130740NIGHTINGALE MONITORING SYSTEMMWI2013-07-23
575342024827882K093802ULTRAVIEW DM3 MONITORDXN2010-04-09
575341828546609K040012WELL@HOME SYSTEMDXN2004-04-02
575341692502834K001775ZOE MEDICAL NIGHTINGALE MONITORING SYSTEMDRT2001-01-12
575341322328496
575341746530000

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWI22015-05-08
DXN22010-04-09
DRT12001-01-12

PMN#