ESCORT II CLINICAL THERMOMETRY MODULE (CTM)— 510(k) K970011
Substantially EquivalentMedical Data Electronics
FDA 510(k) clearance K970011 for ESCORT II CLINICAL THERMOMETRY MODULE (CTM), Substantially Equivalent on 1997-07-09. Applicant: Medical Data Electronics. Device class: 2.
Clearance details
- Applicant
- Medical Data Electronics
- Product code
- Code FLL
- Device class
- Class 2
- Regulation
- 21 CFR 880.2910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arleta, CA, US
Recent devices under product code FLL
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- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
More 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
- K992411 — ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
Adverse events under product code FLL
product code FLL- Death
- 3
- Malfunction
- 557
- Total
- 560
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.