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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 K122060
Device Name CLEVER TD-7001NEBULIZER
Applicant
TaiDoc Technology Corporation
3F,5F, No.127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Applicant Contact PINJUNG CHEN
Correspondent
TaiDoc Technology Corporation
3F,5F, No.127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Correspondent Contact PINJUNG CHEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/13/2012
Decision Date 03/21/2013
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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