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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 K962534
Device Name THERA-MIST NEBULIZER MODEL-P3000
Applicant
Pegasus Research Corp.
2003 S. Ritchey Ave.
Santa Ana,  CA  92705
Applicant Contact MICHAEL HENNIGMAN
Correspondent
Pegasus Research Corp.
2003 S. Ritchey Ave.
Santa Ana,  CA  92705
Correspondent Contact MICHAEL HENNIGMAN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/28/1996
Decision Date 02/28/1997
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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