DR180-II— 510(k) K001288
Substantially EquivalentNorth East Monitoring, Inc.
FDA 510(k) clearance K001288 for DR180-II, Substantially Equivalent on 2000-07-20. Applicant: North East Monitoring, Inc.. Device class: 2.
Clearance details
- Applicant
- North East Monitoring, Inc.
- Product code
- Code MWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Sudbury, MA, US
Recent devices under product code MWJ
view allMore clearances from North East Monitoring, Inc.
view allAdverse events under product code MWJ
product code MWJ- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.