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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 K936046
Device Name SIGMA ELITE
Applicant
Penlon, Inc.
Abingdon Ox 14 3ph
Abingdon Ox,  GB
Applicant Contact G.I. WOND
Correspondent
Penlon, Inc.
Abingdon Ox 14 3ph
Abingdon Ox,  GB
Correspondent Contact G.I. WOND
Regulation Number868.5880
Classification Product Code
CAD  
Date Received12/20/1993
Decision Date 11/04/1994
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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