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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K810731
Device Name MODEL IM1000 INTEGRATED MONITOR
Applicant
Gould, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Gould, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/17/1981
Decision Date 03/27/1981
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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