FDA.report

ULTRASPECT USA, LLC

Matched from indexed company URL: ULTRASPECT LTD.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30187885823018788582ULTRASPECT USA, LLC1N2026-01-01101 Dillion Court Gray TN US 37615

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2916591313256898K103710WBR XPRESS PETKPS2011-01-19
2916591837635447K091073WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONSKPS2009-05-14
2916591004786992K081201WBR XPRESS3.CARDIACKPS2008-05-28
2916591346858268K080784WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONEKPS2008-04-02
2916592007014167K050815XACT.CARDIAC & XPRESS.CARDIACKPS2005-04-26
2916591144510967K040370WBR-FHR, WBR-FWBKPS2004-03-11
2916592035746828K031874MODIFICATION TO WBR, MODEL HRKPS2003-07-18
2916591837379216K030870WBR, MODEL HRKPS2003-04-09

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KPS82011-01-19

PMN

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