The following data is part of a premarket notification filed by Kang Ying Medical Appliances Inc. with the FDA for Digital Temperature Monitor; Model Ky-01.
| Device ID | K030219 |
| 510k Number | K030219 |
| Device Name: | DIGITAL TEMPERATURE MONITOR; MODEL KY-01 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | KANG YING MEDICAL APPLIANCES INC. NO 25, TAI-L 1 ST., JEN-TE HSIANG Tainan County, TW |
| Contact | Ching-chu Chen |
| Correspondent | Ching-chu Chen KANG YING MEDICAL APPLIANCES INC. NO 25, TAI-L 1 ST., JEN-TE HSIANG Tainan County, TW |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-22 |
| Decision Date | 2003-08-05 |
| Summary: | summary |