SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM

Spirometer, Diagnostic

SYNECTICS-DANTEC

The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Synectics Liberty System, Pc Polygraf And Polygram.

Pre-market Notification Details

Device IDK904625
510k NumberK904625
Device Name:SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM
ClassificationSpirometer, Diagnostic
Applicant SYNECTICS-DANTEC RENSTIENAS GATA 12, 5TR. S-116 28 STOCKHOLM Sweden,  SE S-116 28
ContactAnna Pettersson
CorrespondentAnna Pettersson
SYNECTICS-DANTEC RENSTIENAS GATA 12, 5TR. S-116 28 STOCKHOLM Sweden,  SE S-116 28
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-10
Decision Date1991-08-20

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