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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Recorder, Paper Chart
510(k) Number K902230
Device Name COLORADO COLOR IMAGING RECORDER
Applicant
Honeywell, Inc.
P.O. Box 5227
M.S. 219
Denver,  CO  80217
Applicant Contact CARLOS A ORTIZ
Correspondent
Honeywell, Inc.
P.O. Box 5227
M.S. 219
Denver,  CO  80217
Correspondent Contact CARLOS A ORTIZ
Regulation Number870.2810
Classification Product Code
DSF  
Date Received05/17/1990
Decision Date 06/19/1990
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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