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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Balloon, Intra-Aortic And Control
510(k) Number K855102
Device Name MONARK 869 ERGOMETER
Applicant
Equilibrated Bio Systems, Inc.
900 Walt Whitman Rd.
Melville,  NY  11747
Applicant Contact ALEX STENZLER
Correspondent
Equilibrated Bio Systems, Inc.
900 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact ALEX STENZLER
Regulation Number870.3535
Classification Product Code
DSP  
Date Received12/23/1985
Decision Date 05/09/1986
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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