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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K092335
Device Name PEAK EXPIRATORY FLOW METER, KN-9710
Applicant
K-Jump Health Co., Ltd.
# 56, Wu Kung 5th Rd.,
Wu Ku Industrial Park
Taipei Hsien,  TW 248
Applicant Contact JASON CHENG
Correspondent
K-Jump Health Co., Ltd.
# 56, Wu Kung 5th Rd.,
Wu Ku Industrial Park
Taipei Hsien,  TW 248
Correspondent Contact JASON CHENG
Regulation Number868.1860
Classification Product Code
BZH  
Date Received08/04/2009
Decision Date 04/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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