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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaporizer, Anesthesia, Non-Heated
510(k) Number K960944
Device Name PPV VAPORIZER (MODIFICATION)
Applicant
Penlon , Ltd.
Radley Rd.
Aingdon
Oxonn,  GB OX14 3PH
Applicant Contact ALAN C GREEN
Correspondent
Penlon , Ltd.
Radley Rd.
Aingdon
Oxonn,  GB OX14 3PH
Correspondent Contact ALAN C GREEN
Regulation Number868.5880
Classification Product Code
CAD  
Date Received02/13/1996
Decision Date 04/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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