Data / Medical devices / United States / Northeast Monitoring, Inc.
Northeast Monitoring, Inc.: FDA-registered device maker in Maynard, MA, United States, 3 510(k) clearances
Northeast Monitoring, Inc. is registered with the FDA (registration 1224919) in Maynard, MA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 25, 2014. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 1224919
- FEI number
- 1000513706
- Address
- 141 Parker Street, Suite # 200, Maynard, MA, United States, 01754
- Owner or operator
- NORTHEAST MONITORING, INC. (9021067)
- Roles
- Manufacturer
- First device listed
- November 12, 2007
- Registered through
- 2027
- Brand names listed
- DR200, DR200 Series, DR200/Ea, DR200/HE, DR200/HEa, DR300 Holter Recorder, DR400 Holter Patch Recorder, Holter LX Analysis, LX Event and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 25, 2014 | K142424 | DR300 HOLTER MONITOR | MWJ | Substantially Equivalent | North East Monitoring, Inc. | accessdata.fda.gov |
| August 25, 2006 | K061293 | TELAHEART DIGITAL RECORDER | MWJ | Substantially Equivalent | North East Monitoring, Inc. | accessdata.fda.gov |
| April 19, 1995 | K930564 | HOLTER FOR WINDOWS | DQK | Substantially Equivalent | North East Monitoring, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of Electrocardiograph, Ambulatory (Without Analysis)
Updated November 25, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.