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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K983114
Device Name MAGNATEK80
Applicant
Magna Advanced Technologies, Inc.
7200 NW Seventh St.
2nd Floor
Miami,  FL  33126
Applicant Contact ANNIE VELEZ
Correspondent
Magna Advanced Technologies, Inc.
7200 NW Seventh St.
2nd Floor
Miami,  FL  33126
Correspondent Contact ANNIE VELEZ
Regulation Number868.1400
Classification Product Code
CCK  
Date Received09/04/1998
Decision Date 09/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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