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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K854639
Device Name BIOMECCA CENTRAL CS1
Applicant
Biomecca Australia , Ltd.
Cavinton & Burling
1201 Pa. Ave.,NW P.O. Box 7566
Washington,  DC  20044
Applicant Contact ELLEN J FLANNERY
Correspondent
Biomecca Australia , Ltd.
Cavinton & Burling
1201 Pa. Ave.,NW P.O. Box 7566
Washington,  DC  20044
Correspondent Contact ELLEN J FLANNERY
Regulation Number870.2300
Classification Product Code
DRT  
Date Received11/19/1985
Decision Date 04/17/1986
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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