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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 K980024
Device Name SHINMED MODEL SW-966 ULTRASONIC NEBULIZER
Applicant
SHINING WORLD HEALTH CARE CO., LTD.
6F, NO. 8, LANE 7, WU-CHUN RD.
WU-KU INDUSTRIAL PARK
TAIPEI HSIEN,  TW 24886
Applicant Contact CAROLANN KOTULA
Correspondent
SHINING WORLD HEALTH CARE CO., LTD.
6F, NO. 8, LANE 7, WU-CHUN RD.
WU-KU INDUSTRIAL PARK
TAIPEI HSIEN,  TW 24886
Correspondent Contact CAROLANN KOTULA
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/05/1998
Decision Date 09/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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