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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Amplifier And Signal Conditioner, Transducer Signal
510(k) Number K830914
Device Name EXTERNAL VALVE FUNCTION BLOCK
Applicant
Honeywell, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Honeywell, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2060
Classification Product Code
DRQ  
Date Received03/24/1983
Decision Date 08/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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