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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Patient Isolation
510(k) Number K912444
Device Name MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
Applicant
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145
Applicant Contact KATHLEEN M ONTKO
Correspondent
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145
Correspondent Contact KATHLEEN M ONTKO
Regulation Number880.5450
Classification Product Code
LGM  
Date Received06/03/1991
Decision Date 02/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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