The following data is part of a premarket notification filed by Fora Care Inc. with the FDA for Fora Comfortscan Ear Thermometer.
| Device ID | K121118 |
| 510k Number | K121118 |
| Device Name: | FORA COMFORTSCAN EAR THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | FORA CARE INC. 3F, 5F, 6F, NO.127, WUGONG 2ND RD., WUGU TOWNSHIP Taipei County, TW 24888 |
| Contact | Pinjung Chen |
| Correspondent | Pinjung Chen FORA CARE INC. 3F, 5F, 6F, NO.127, WUGONG 2ND RD., WUGU TOWNSHIP Taipei County, TW 24888 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-12 |
| Decision Date | 2012-06-15 |
| Summary: | summary |