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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 K955113
Device Name DINAMAP SELECT MULTI-PARAMETER SYSTEM
Applicant
Johnson & Johnson Medical, Inc.
4110 George Rd.
Tampa,  FL  33634
Applicant Contact ANNETTE M HILRING
Correspondent
Johnson & Johnson Medical, Inc.
4110 George Rd.
Tampa,  FL  33634
Correspondent Contact ANNETTE M HILRING
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/08/1995
Decision Date 08/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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