K120815 is an FDA 510(k) clearance for the INNERSENSE ESOPHAGEAL TEMPERATURE/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 March 6, 2013, 352 days after receiving the submission on March 19, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K120815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2012 |
| Decision Date | March 06, 2013 |
| Days to Decision | 352 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 |