The following data is part of a premarket notification filed by Medivance, Inc. with the FDA for Medivance Nasogastric Tube Temperature Sensor.
| Device ID | K110956 |
| 510k Number | K110956 |
| Device Name: | MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MEDIVANCE, INC. 321 SOUTH TAYLOR AVE, STE 200 Louisville, CO 80027 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson MEDIVANCE, INC. 321 SOUTH TAYLOR AVE, STE 200 Louisville, CO 80027 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-05 |
| Decision Date | 2011-07-18 |
| Summary: | summary |