FDA 510(k) Application Details - K002727

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K002727
Device Name Thermometer, Electronic, Clinical
Applicant YOUNG HEALTH IND. CO., LTD.
N0.7 NANKANN SHIAH, LU-CHU
SHIANG
TAOYUAN HSIEN 338 TW
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Contact YANG RONK-JEH
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 08/31/2000
Decision Date 06/13/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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