The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Innersense Esophageal Temperature Probe / Feeding Tube.
| Device ID | K131590 |
| 510k Number | K131590 |
| Device Name: | INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE |
| Classification | Tube, Feeding |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD Andover, MA 01810 |
| Contact | Christine Trefethen |
| Correspondent | Christine Trefethen PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD Andover, MA 01810 |
| Product Code | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-31 |
| Decision Date | 2013-10-23 |
| Summary: | summary |