The following data is part of a premarket notification filed by Omron Electronics, Inc. with the FDA for Omron Digital Fever Thermometer Model Mc-12b.
| Device ID | K872527 |
| 510k Number | K872527 |
| Device Name: | OMRON DIGITAL FEVER THERMOMETER MODEL MC-12B |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | OMRON ELECTRONICS, INC. ONE EAST COMMERCE DR. Schaumburg, IL 60173 |
| Contact | Oishi |
| Correspondent | Oishi OMRON ELECTRONICS, INC. ONE EAST COMMERCE DR. Schaumburg, IL 60173 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-25 |
| Decision Date | 1987-07-23 |