FDA.reportPublic FDA data

DIVERSATEK HEALTHCARE INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20233742023374DIVERSATEK HEALTHCARE INC.1Y2026-01-019150 Commerce Center Cir Ste 500 Highlands Ranch CO US 80129

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
343222061655848K971214KILOWINGWE1998-06-11
343221203557380K961056BIOVIEW MODEL S960000KLA1996-06-06
343221552946265K931963SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBEFFT1994-09-28
343221206094879K823701MOTILITY CATHETERSFFX1983-02-15
343221891940739K230056MiVu™ Esophageal Endo CapQIS2023-04-25
343221315595554K190208Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeFFX2019-10-03
343221913200037K111013ACEMFFZ2011-12-19
343221956253021K062222UNITIP HIGH RESOLUTION CATHETERFFX2007-03-15
343221000303481K022023COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500KLA2003-01-07
343221409249042K013951SANDHILL SCIENTIFIC PEDIATEC PH PROBEFFT2002-02-28
343221622113643K012232INSIGHT, MODEL S980000FFX2002-06-07
343221034231749DEN180067Mucosal Integrity Conductivity (MI) Test SystemQIS2019-12-23
343221907208818

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FFX42019-10-03
QIS32023-04-25
FFT32002-02-28
KLA22003-01-07
FFZ12011-12-19
GWE11998-06-11