TREND PROCESSOR OPTION FOR #515 NEONAT— 510(k) K833552
Substantially EquivalentGe Medical Systems Information Technologies
FDA 510(k) clearance K833552 for TREND PROCESSOR OPTION FOR #515 NEONAT, Substantially Equivalent on 1984-01-27. Applicant: Ge Medical Systems Information Technologies.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies
- Product code
- Code DRT
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code DRT
product code DRT- Death
- 4
- Total
- 4
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.