The following data is part of a premarket notification filed by Fudakang Industrial Co Ltd with the FDA for Infrared Ear Therometer.
| Device ID | K111703 |
| 510k Number | K111703 |
| Device Name: | INFRARED EAR THEROMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | FUDAKANG INDUSTRIAL CO LTD 205 S. BROADWAY, SUITE 718 Los Angeles, CA 90012 |
| Contact | Daniel Nam |
| Correspondent | Daniel Nam FUDAKANG INDUSTRIAL CO LTD 205 S. BROADWAY, SUITE 718 Los Angeles, CA 90012 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-17 |
| Decision Date | 2012-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859020006208 | K111703 | 000 |
| 16955647600070 | K111703 | 000 |
| 10859020006472 | K111703 | 000 |
| 00859020006444 | K111703 | 000 |
| 00894046001042 | K111703 | 000 |
| 00859020006048 | K111703 | 000 |
| 00859020006055 | K111703 | 000 |
| 20859020006066 | K111703 | 000 |
| 00859020006079 | K111703 | 000 |
| 00859020006383 | K111703 | 000 |