The following data is part of a premarket notification filed by Global Treasure Industries Ltd. with the FDA for Standard Thermometer.
Device ID | K030658 |
510k Number | K030658 |
Device Name: | STANDARD THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | GLOBAL TREASURE INDUSTRIES LTD. 163 CABOT ST. Beverly, MA 01915 |
Contact | Fran White |
Correspondent | Fran White GLOBAL TREASURE INDUSTRIES LTD. 163 CABOT ST. Beverly, MA 01915 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-03 |
Decision Date | 2003-03-25 |
Summary: | summary |