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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Gas-Scavenging
510(k) Number K915287
Device Name ISOL-AIDE
Applicant
COMPUTRONIC SYSTEMS
7000 GRANGER RD.
CLEVELAND,  OH  44131
Applicant Contact TIMOTHY P NELSON
Correspondent
COMPUTRONIC SYSTEMS
7000 GRANGER RD.
CLEVELAND,  OH  44131
Correspondent Contact TIMOTHY P NELSON
Regulation Number868.5430
Classification Product Code
CBN  
Date Received11/21/1991
Decision Date 10/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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