The following data is part of a premarket notification filed by Global Treasure Industries Ltd. with the FDA for Model Gt010706 Electronic Thermometer.
Device ID | K021052 |
510k Number | K021052 |
Device Name: | MODEL GT010706 ELECTRONIC THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | GLOBAL TREASURE INDUSTRIES LTD. NAN FUNG IND. CIT 18 TIN HAU ROAD Tuen Mun N.t., HK |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2002-04-01 |
Decision Date | 2002-04-09 |
Summary: | summary |