FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

FLEXIBLE TIP THERMOMETER, MODEL 011206

K Number: K030673 · Decision Apr 4, 2003
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
5
Review Days
31

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Basic Information

Device Name
FLEXIBLE TIP THERMOMETER, MODEL 011206
K Number
K030673
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.2910
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Global Treasure Industries , Ltd.
Date Received
March 4, 2003
Decision Date
April 4, 2003
Product Code
FLL
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FLL Continuous Measurement Thermometer

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Other Clearances by Global Treasure Industries , Ltd.

K Number Device Name
K062010 RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES
K043033 GLOBAL TREASURES FLUID FILLED TEETHER
K030658 STANDARD THERMOMETER
K021052 MODEL GT010706 ELECTRONIC THERMOMETER