The following data is part of a premarket notification filed by Geon Corporation with the FDA for Geon Rapid Digital Thermometer Model: Mt-b117, Mt-b127, Mt-b130, Mt-b132fa.
| Device ID | K100563 |
| 510k Number | K100563 |
| Device Name: | GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | GEON CORPORATION 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich GEON CORPORATION 2904 N. BOLDT DRIVE Flagstaff, 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 | 2010-03-01 |
| Decision Date | 2010-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782563103 | K100563 | 000 |
| 00634782563097 | K100563 | 000 |
| 00634782563080 | K100563 | 000 |
| 00634782563073 | K100563 | 000 |