ESCORT II CLINICAL THERMOMETRY MODULE (CTM)— 510(k) K970011

Substantially Equivalent

Medical Data Electronics

FDA 510(k) clearance K970011 for ESCORT II CLINICAL THERMOMETRY MODULE (CTM), Substantially Equivalent on 1997-07-09. Applicant: Medical Data Electronics.

Clearance details

Applicant: Medical Data Electronics
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1997-01-02
Decision date: 1997-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arleta, CA, US

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Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.