The following data is part of a premarket notification filed by Geon Corp. with the FDA for Geon Digital Clinical Thermometer.
| Device ID | K003223 |
| 510k Number | K003223 |
| Device Name: | GEON DIGITAL CLINICAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | GEON CORP. 900 N. SWITZER CANYOU DR. SUITE 142 Flaggstaff, AZ 86001 |
| Contact | Allen Reich |
| Correspondent | Allen Reich GEON CORP. 900 N. SWITZER CANYOU DR. SUITE 142 Flaggstaff, AZ 86001 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-16 |
| Decision Date | 2001-01-12 |