The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Tympanic Temperature Probe With Foam, Model M1024233; Without Foam Model M1024237.
| Device ID | K061942 |
| 510k Number | K061942 |
| Device Name: | TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237 |
| 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 | 2006-07-10 |
| Decision Date | 2006-09-29 |
| Summary: | summary |