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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K863100
Device Name CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR
Applicant
Honeywell, Inc.
One Campus Dr.
Pleasantville,  NY  10570
Applicant Contact STEVE BRODY
Correspondent
Honeywell, Inc.
One Campus Dr.
Pleasantville,  NY  10570
Correspondent Contact STEVE BRODY
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/13/1986
Decision Date 02/03/1987
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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