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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Air Fluidized
510(k) Number K884529
Device Name MICROAIR FLUIDIZED AIR BED
Applicant
Gsi Development Co.
2 Commerce Dr.
Carmel,  NY  10512
Applicant Contact BODINE, JR
Correspondent
Gsi Development Co.
2 Commerce Dr.
Carmel,  NY  10512
Correspondent Contact BODINE, JR
Regulation Number890.5160
Classification Product Code
INX  
Date Received10/28/1988
Decision Date 11/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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