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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, Pre-Programmed, Single-Function
510(k) Number K894234
Device Name SENSOCOR TM R-TEST 24OXL
Applicant
Sensocor
750 E. Sample Rd.
Pompano Beach,  FL  33064
Applicant Contact ROBERT SILVER
Correspondent
Sensocor
750 E. Sample Rd.
Pompano Beach,  FL  33064
Correspondent Contact ROBERT SILVER
Regulation Number870.1435
Classification Product Code
DXG  
Date Received06/20/1989
Decision Date 08/03/1989
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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