The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Innersense Esophageal Temperature/feeding Tube.
| Device ID | K120815 |
| 510k Number | K120815 |
| Device Name: | INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE |
| Classification | Tube, Feeding |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Peter Schipelliti |
| Correspondent | Peter Schipelliti PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2013-03-06 |
| Summary: | summary |