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. Device class: 2.
Clearance details
- Applicant
- Medical Data Electronics
- Product code
- Code DRT
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Arleta, CA, US
Recent devices under product code DRT
view allMore clearances from Medical Data Electronics
view all- K014294 — MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414
- K012336 — MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
- K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
- K992413 — ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
- K982104 — ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
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.