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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K860790
Device Name BIOMECCA CARETAKER 1000 & 2000
Applicant
Biomecca Australia , Ltd.
48a Chapel St.
Marrickville, Sydney,  AU NSW 2204
Applicant Contact PETER LAMBERT
Correspondent
Biomecca Australia , Ltd.
48a Chapel St.
Marrickville, Sydney,  AU NSW 2204
Correspondent Contact PETER LAMBERT
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/04/1986
Decision Date 05/08/1986
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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