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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K872113
Device Name OMNI-VENT, SERIES D
Applicant
Stein-Gates Medical Equipment, Inc.
121 N. Fourth St.
Atchison,  KS  66002
Applicant Contact GATES, BS
Correspondent
Stein-Gates Medical Equipment, Inc.
121 N. Fourth St.
Atchison,  KS  66002
Correspondent Contact GATES, BS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/01/1987
Decision Date 03/23/1988
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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