North East Monitoring, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 10
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K142424 | DR300 HOLTER MONITOR | November 25, 2014 |
| K081861 | HOLTER LX ANALYSIS | December 4, 2008 |
| K070014 | AUTO DETECT FOR TELAHEART DR200/E-A | May 25, 2007 |
| K061293 | TELAHEART DIGITAL RECORDER | August 25, 2006 |
| K041901 | SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER | August 31, 2004 |
| K004007 | DR180+OXY | January 25, 2001 |
| K001288 | DR180-II | July 20, 2000 |
| K983576 | DR180-R/OXY | March 23, 1999 |
| K960925 | NORTHEAST MONITORING DR180 | July 31, 1996 |
| K930564 | HOLTER FOR WINDOWS | April 19, 1995 |