INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE— 510(k) K131590
Substantially EquivalentPhilips Medical Systems
FDA 510(k) clearance K131590 for INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE, Substantially Equivalent on 2013-10-23. Applicant: Philips Medical Systems. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems
- Product code
- Code FPD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- 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, 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.