The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Reusable Temperature Probes (m1024254 Skin Temperature Probe, Reusable; M1024247, Gp Temperature Probe, Adult, Resuable.
| Device ID | K050837 |
| 510k Number | K050837 |
| Device Name: | REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel 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 | 2005-04-01 |
| Decision Date | 2005-04-27 |
| Summary: | summary |