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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 K880473
Device Name AERO-MIST NEBULIZER HEATER
Applicant
Pegasus Research Corp.
3334 E. Coast Hwy., Suite
297
Corona Del Mar,  CA  92625
Applicant Contact KENNETH G MILLER
Correspondent
Pegasus Research Corp.
3334 E. Coast Hwy., Suite
297
Corona Del Mar,  CA  92625
Correspondent Contact KENNETH G MILLER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/04/1988
Decision Date 03/31/1988
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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