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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 K875134
Device Name OMRON ULTRASONIC NEBULIZER NE-U06
Applicant
Nidek, Inc.
2706 S. 19th St.
Birmingham,  AL  35209
Applicant Contact ANAND CHITLANGIA
Correspondent
Nidek, Inc.
2706 S. 19th St.
Birmingham,  AL  35209
Correspondent Contact ANAND CHITLANGIA
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/15/1987
Decision Date 12/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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