The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Disposable Temperature, Skin And Esophageal Probes.
| Device ID | K051873 |
| 510k Number | K051873 |
| Device Name: | DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-11 |
| Decision Date | 2005-09-20 |
| Summary: | summary |