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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K943081
Device Name TRIMLINE 2000
Applicant
Pymah Corp.
89 Rte. 206
P.O. Box 1114
Somerville,  NJ  08876
Applicant Contact GEORGE LEVENDUSKY
Correspondent
Pymah Corp.
89 Rte. 206
P.O. Box 1114
Somerville,  NJ  08876
Correspondent Contact GEORGE LEVENDUSKY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/28/1994
Decision Date 01/27/1995
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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