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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 K053203
Device Name MYNEB NEBULIZER, MODEL RDD100
Applicant
Respironics New Jersey, Inc.
41 Canfield Rd.
Cedar Grove,  NJ  07009
Applicant Contact Lauren Ziegler
Correspondent
Intertek Testing Services
70 Codman Hill Rd.
Boxborough,  MA  01719
Correspondent Contact DANIEL W LEHTONEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/16/2005
Decision Date 12/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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