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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 K853501
Device Name HONEYWELL ELECTRONIC VENTILATOR EV-A
Applicant
Honeywell, Inc.
One Campus Dr.
Pleasantville,  NY  10570
Applicant Contact MARTIN KUTIK
Correspondent
Honeywell, Inc.
One Campus Dr.
Pleasantville,  NY  10570
Correspondent Contact MARTIN KUTIK
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/20/1985
Decision Date 04/04/1986
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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