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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K893950
Device Name VENTIPRESS 24 AND 14 PRESSURE VENTILATOR
Applicant
Ventipress OY
Juvola, Sf-54850
Kuukanniemi
Finland,  FI
Applicant Contact PERTTI J KOLARI
Correspondent
Ventipress OY
Juvola, Sf-54850
Kuukanniemi
Finland,  FI
Correspondent Contact PERTTI J KOLARI
Regulation Number890.5650
Classification Product Code
IRP  
Date Received06/01/1989
Decision Date 08/03/1989
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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