GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE— 510(k) K121999

Substantially Equivalent

Draeger Medical GmbH

FDA 510(k) clearance K121999 for GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE, Substantially Equivalent on 2013-02-28. Applicant: Draeger Medical GmbH.

Clearance details

Applicant: Draeger Medical GmbH
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2012-07-09
Decision date: 2013-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, 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.