FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.

K Number: K072641 · Decision Nov 1, 2007
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
6
Review Days
44

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Basic Information

Device Name
DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.
K Number
K072641
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.2910
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Famidoc Technology Co., Ltd.
Date Received
September 18, 2007
Decision Date
November 1, 2007
Product Code
FLL
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
Y

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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K113010 FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
K113761 INFRARED THERMOMETER
K052849 INFRARED THERMOMETER, FDIR-V1