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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 K031686
Device Name AEROMIST LT, MODEL HCS15004
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Applicant Contact ANDREA HAFERKAMP
Correspondent
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN,  IL  60060
Correspondent Contact ANDREA HAFERKAMP
Regulation Number868.6250
Classification Product Code
BTI  
Date Received06/02/2003
Decision Date 01/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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