Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1224919

FEI Number

1000513706

Entity Name

NORTHEAST MONITORING, INC.

City/State/Country

MAYNARD, MA, US

Establishment Address

141 Parker Street, Suite # 200, MAYNARD, MA 01754, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NORTHEAST MONITORING, INC. (Owner Number: 9021067)

Owner / Operator Contact Address

141 Parker Street, Suite #200, Maynard, MA 01754, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K930564

PMA Number

N/A

All Registered Proprietary Names

DR300 Holter Recorder, DR400 Holter Patch Recorder Holter LX Analysis

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2015-01-02
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2007-11-12

Official Correspondent

SHERRY STEELE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NORTHEAST MONITORING, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1224919. Last updated year: 2026. Please use registration number 1224919 when referencing this establishment in official correspondence.