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

DIGITAL CLINICAL THERMOMETER, MODEL KD-193

K Number: K021851 · Decision Jul 17, 2002
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
26
Review Days
42

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Basic Information

Device Name
DIGITAL CLINICAL THERMOMETER, MODEL KD-193
K Number
K021851
Device Class
FDA class 2
Clearance Type
Abbreviated
Regulation Number
880.2910
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
K-Jump Health Co., Ltd.
Date Received
June 5, 2002
Decision Date
July 17, 2002
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 K-Jump Health Co., Ltd.

K Number Device Name
K180714 Probe Covers for Thermometers
K170262 Digital Thermometer
K141505 BASAL DIGITAL THERMOMETER
K121520 ULTRASONIC NEBULIZER (MESH TYPE)
K120711 NON-CONTACT THERMOMETER
K103617 DIGITAL FOREHEAD THERMOMETER
K102947 NON-CONTACT INFRARED THERMOMETER
K092335 PEAK EXPIRATORY FLOW METER, KN-9710
K092806 AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770
K083256 ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
Search all 26 clearances from K-Jump Health Co., Ltd. →