DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300— 510(k) K070878

Substantially Equivalent

Rg Medical Diagnostics

FDA 510(k) clearance K070878 for DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300, Substantially Equivalent on 2007-06-05. Applicant: Rg Medical Diagnostics.

Clearance details

Applicant: Rg Medical Diagnostics
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2007-03-29
Decision date: 2007-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southfield, MI, 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.