The following data is part of a premarket notification filed by Hivox Biotek, Inc. with the FDA for Hivox Ear Thermometer, Ts Series.
| Device ID | K020471 |
| 510k Number | K020471 |
| Device Name: | HIVOX EAR THERMOMETER, TS SERIES |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HIVOX BIOTEK, INC. 12F, NO.156, SEC.1,CHIEN KUO NORTH RD. Taipei, TW 104 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen HIVOX BIOTEK, INC. 12F, NO.156, SEC.1,CHIEN KUO NORTH RD. Taipei, TW 104 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-12 |
| Decision Date | 2002-05-02 |
| Summary: | summary |