ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR— 510(k) K992411
Substantially EquivalentMedical Data Electronics
FDA 510(k) clearance K992411 for ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR, Substantially Equivalent on 1999-08-18. Applicant: Medical Data Electronics.
Clearance details
- Applicant
- Medical Data Electronics
- Product code
- Code DRT
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Arleta, CA, 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.