The following data is part of a premarket notification filed by E-care Technology Corporation with the FDA for E-care Infrared Ear Thermometer.
| Device ID | K113095 |
| 510k Number | K113095 |
| Device Name: | E-CARE INFRARED EAR THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | E-CARE TECHNOLOGY CORPORATION 8F-11 NO. 35 HSIN-TAI ROAD Chubei, TW 30252 |
| Contact | Kin-yuan Ko |
| Correspondent | Kin-yuan Ko E-CARE TECHNOLOGY CORPORATION 8F-11 NO. 35 HSIN-TAI ROAD Chubei, TW 30252 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-19 |
| Decision Date | 2012-03-02 |
| Summary: | summary |