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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Blood-Pressure
510(k) Number K782073
Device Name DINAMAP MODELS 1160 AND 1165
Applicant
Applied Medical Research
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Applied Medical Research
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1110
Classification Product Code
DSK  
Date Received12/13/1978
Decision Date 02/23/1979
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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