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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress, Air Flotation, Alternating Pressure
510(k) Number K944310
Device Name PEGASUS BIWAVE PLUS SYSTEM
Applicant
Pegasus Airwave, Inc.
640 S. Militay Trl.
Deerfield Beach,  FL  33442
Applicant Contact THOMAS R HARRISION
Correspondent
Pegasus Airwave, Inc.
640 S. Militay Trl.
Deerfield Beach,  FL  33442
Correspondent Contact THOMAS R HARRISION
Regulation Number880.5550
Classification Product Code
FNM  
Date Received09/02/1994
Decision Date 03/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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