K131590 is an FDA 510(k) clearance for the INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE. This device is classified as a Tube, Feeding (Class II - Special Controls, product code FPD).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on October 23, 2013, 145 days after receiving the submission on May 31, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K131590 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2013 |
| Decision Date | October 23, 2013 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FPD — Tube, Feeding |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |