SEER LIGHT COMPACT DIGITAL HOLTER RECORDER— 510(k) K021470
Substantially EquivalentGeneral Electric Medical Systems Information Techn
FDA 510(k) clearance K021470 for SEER LIGHT COMPACT DIGITAL HOLTER RECORDER, Substantially Equivalent on 2002-11-14. Applicant: General Electric Medical Systems Information Techn.
Clearance details
- Applicant
- General Electric Medical Systems Information Techn
- Product code
- Code MWJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milwaukee, WI, 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.