The following data is part of a premarket notification filed by Global Treasure Ltd. with the FDA for Gt990402 Digital Thermometer.
| Device ID | K001279 |
| 510k Number | K001279 |
| Device Name: | GT990402 DIGITAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | GLOBAL TREASURE LTD. BLOCK2, 5/F,. ROOM 8 NAN FUNG IND. CITY 18 Tin Hau Road, Tuen Mun N.t., HK |
| Contact | Ben Ma |
| Correspondent | N. E. Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-04-21 |
| Decision Date | 2000-04-28 |