The following data is part of a premarket notification filed by Global Treasure Industries Ltd. with the FDA for Rapid Digital Thermometer, Model Rdt -18 Series.
| Device ID | K062010 |
| 510k Number | K062010 |
| Device Name: | RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | GLOBAL TREASURE INDUSTRIES LTD. 2108 CIRO'S PLAZA 388 WEST NANJING ROAD Shanghai, CN 20003 |
| Contact | Janice Ma |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-07-17 |
| Decision Date | 2006-10-27 |
| Summary: | summary |