TRIMLINE 2000

System, Measurement, Blood-pressure, Non-invasive

PYMAH CORP.

The following data is part of a premarket notification filed by Pymah Corp. with the FDA for Trimline 2000.

Pre-market Notification Details

Device IDK943081
510k NumberK943081
Device Name:TRIMLINE 2000
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant PYMAH CORP. 89 ROUTE 206 P.O. BOX 1114 Somerville,  NJ  08876
ContactGeorge Levendusky
CorrespondentGeorge Levendusky
PYMAH CORP. 89 ROUTE 206 P.O. BOX 1114 Somerville,  NJ  08876
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-28
Decision Date1995-01-27

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