SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER— 510(k) K041901
Substantially EquivalentNorth East Monitoring, Inc.
FDA 510(k) clearance K041901 for SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER, Substantially Equivalent on 2004-08-31. Applicant: North East Monitoring, Inc..
Clearance details
- Applicant
- North East Monitoring, Inc.
- Product code
- Code MWJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Shelton, CT, US
Adverse 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.