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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 K922923
Device Name NE-U07
Applicant
OMRON HEALTHCARE, INC.
300 LAKEVIEW PKWY.
VERNON HILLS,  IL  60061
Applicant Contact TERRENCE O'BRIEN
Correspondent
OMRON HEALTHCARE, INC.
300 LAKEVIEW PKWY.
VERNON HILLS,  IL  60061
Correspondent Contact TERRENCE O'BRIEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/17/1992
Decision Date 09/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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