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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K844104
Device Name CARDIO ANALYZER MODEL 380
Applicant
Birtcher Corp.
4501 N. Arden Dr.
P.O. Box 4399
El Monte,  CA  91731
Applicant Contact ENRIQUE RANGEL
Correspondent
Birtcher Corp.
4501 N. Arden Dr.
P.O. Box 4399
El Monte,  CA  91731
Correspondent Contact ENRIQUE RANGEL
Classification Product Code
LOS
Date Received10/23/1984
Decision Date 03/06/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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