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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 K981944
Device Name BREATHERITE
Applicant
VENTLAB CORP.
PO BOX 4341
CROFTON,  MD  21114 -4341
Applicant Contact E.J. Smith
Correspondent
VENTLAB CORP.
PO BOX 4341
CROFTON,  MD  21114 -4341
Correspondent Contact E.J. Smith
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/03/1998
Decision Date 08/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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