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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K903489
Device Name THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000
Applicant
Pegasus Research Corp.
3001 Redhill Ave., Suite 4-
119
Costa Mesa,  CA  92626
Applicant Contact KENNETH G MILLER
Correspondent
Pegasus Research Corp.
3001 Redhill Ave., Suite 4-
119
Costa Mesa,  CA  92626
Correspondent Contact KENNETH G MILLER
Regulation Number868.5690
Classification Product Code
BWF  
Date Received08/02/1990
Decision Date 12/10/1990
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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