INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE— 510(k) K120815

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K120815 for INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE, Substantially Equivalent on 2013-03-06. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code FPD
Advisory panel: Gastroenterology, Urology
Date received: 2012-03-19
Decision date: 2013-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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Adverse events under product code FPD

product code FPD

Death: 6
Other: 1
Total: 7

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.