FDA.reportPublic FDA data

Norav Medical Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30089773583008977358Norav Medical Inc.1Y2026-01-011300 Wallace Dr Delray Beach FL US 33444

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1342751584374873K161062NR RecorderMWJ2016-06-13
1342751334884139K111487NH-301 AMBULATORY ECG ANALYSIS SOFTWAREMLO2011-11-10
1342751859355806K110463PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)MWI2011-11-10
1342751788834213K080141PC ECG 1200W SYSTEMMWI2008-04-25
1342751736719099K012712NORAV HOLTER SYSTEM, MODEL NH-300 V1.07MLO2002-05-08
1342751571583339K000404PC ECG 1200MWI2000-11-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWI32011-11-10
MLO22011-11-10
MWJ12016-06-13