FDA.reportPublic FDA data

NORTHEAST MONITORING, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12249191000513706NORTHEAST MONITORING, INC.1N2026-01-01141 Parker Street, Suite # 200 MAYNARD MA US 01754

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
510631559438175K960925NORTHEAST MONITORING DR180DSH1996-07-31
510631234134067K930564HOLTER FOR WINDOWSDQK1995-04-19
510632071820083K142424DR300 HOLTER MONITORMWJ2014-11-25
510631002288867K081861HOLTER LX ANALYSISMNR2008-12-04
510631052439667K070014AUTO DETECT FOR TELAHEART DR200/E-AMWJ2007-05-25
510631489634978K061293TELAHEART DIGITAL RECORDERMWJ2006-08-25
510631511455964K004007DR180+OXYDSH2001-01-25
510631674203660K001288DR180-IIMWJ2000-07-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWJ42014-11-25
DSH22001-01-25
MNR12008-12-04
DQK11995-04-19

PMN#

DR180+OXY

2001-01-25

NORTHEAST MONITORING, INC.

DR180-II

2000-07-20

NORTHEAST MONITORING, INC.

GUDID#