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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name compressor, air, portable
510(k) Number K031413
Device Name VIGORMIST COMPRESSOR NEBULIZER
Applicant
VEGA TECHNOLOGIES, INC.
11F-13, 100 CHANG-CHUN RD.
TAIPEI,  TW 104
Applicant Contact JOSEPH LU
Correspondent
CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL
BLDG. 16, 321 KUANG FU RD,SEC2
HSINCHU,,  TW
Correspondent Contact TZU-WEI LI
Regulation Number868.6250
Classification Product Code
BTI  
Subsequent Product Code
CAF  
Date Received05/05/2003
Decision Date 10/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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