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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 K972657
Device Name ULTRAMIST 2000
Applicant
Texas Medical Industries, Inc.
1409 Industrial Park
Royse City,  TX  75189
Applicant Contact STEVE HARLOW
Correspondent
Texas Medical Industries, Inc.
1409 Industrial Park
Royse City,  TX  75189
Correspondent Contact STEVE HARLOW
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/15/1997
Decision Date 02/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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