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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K121520
Device Name ULTRASONIC NEBULIZER (MESH TYPE)
Applicant
K-Jump Health Co., Ltd.
# 56, Wu Kung 5th Rd.,
New Taipei Indust Park
New Taipei,  TW 24890
Applicant Contact JM LIN
Correspondent
K-Jump Health Co., Ltd.
# 56, Wu Kung 5th Rd.,
New Taipei Indust Park
New Taipei,  TW 24890
Correspondent Contact JM LIN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/22/2012
Decision Date 03/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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