# North East Monitoring, Inc.

- Location (FDA's records): Sudbury, MA
- FDA decisions: 10 (1995–2014): 10 510(k) clearances
- Product codes: MWJ (5), DSH (2), DQK (1), FLL (1), MNR (1)
- Predicates its devices cite: 10 (7 its own); citations of its devices by later devices: 16 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Universal Medical, Inc.: 1 (https://510kreport.com/company/universal-medical)
- Del Mar Reynolds Medical, Ltd.: 1 (https://510kreport.com/company/del-mar-reynolds-medical)
- Braemar, Inc.: 1 (https://510kreport.com/company/braemar)

## Firms that cite its devices most
- Getemed Medizin- Und Informationstechnik AG: 2 (https://510kreport.com/company/getemed-medizin-und-informationstechnik)
- Rozinn Electronics, Inc.: 2 (https://510kreport.com/company/rozinn-electronics)
- Memtec Corp.: 1 (https://510kreport.com/company/memtec)
- Ela Medical, Inc.: 1 (https://510kreport.com/company/ela-medical)
- Neptec Design Group, Ltd.: 1 (https://510kreport.com/company/neptec-design-group)
- Pulse Biomedical, Inc.: 1 (https://510kreport.com/company/pulse-biomedical)
- Edan Instruments, Inc.: 1 (https://510kreport.com/company/edan-instruments)

## Its most-cited devices
- K930564: Holter for Windows (1995), cited by 5
- K001288: DR180-II (2000), cited by 3
- K061293: Telaheart Digital Recorder (2006), cited by 2
- K004007: DR180+OXY (2001), cited by 2
- K960925: Northeast Monitoring DR180 (1996), cited by 1
- K041901: SD360 Digital Recorder/SD360 Holter Digital Recorder (2004), cited by 1

## Recent decisions
- K142424: DR300 Holter Monitor (Nov 25, 2014)
- K081861: Holter LX Analysis (Dec 4, 2008)
- K070014: Auto Detect for Telaheart DR200/E-a (May 25, 2007)
- K061293: Telaheart Digital Recorder (Aug 25, 2006)
- K041901: SD360 Digital Recorder/SD360 Holter Digital Recorder (Aug 31, 2004)
- K004007: DR180+OXY (Jan 25, 2001)
- K001288: DR180-II (Jul 20, 2000)
- K983576: DR180-R/Oxy (Mar 23, 1999)

Source page: https://510kreport.com/company/north-east-monitoring