SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM— 510(k) K050731
Substantially EquivalentGe Medical Systems Information Technologies
FDA 510(k) clearance K050731 for SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM, Substantially Equivalent on 2005-05-19. Applicant: Ge Medical Systems Information Technologies.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies
- 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.