Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter And Bact-HME Midi HME/Filter

Filter, Bacterial, Breathing-circuit

Pharma System AB

The following data is part of a premarket notification filed by Pharma System Ab with the FDA for Bact-trap Filter, Bact-trap Mini, Bact-trap Midi, Pharma Mini Hme/filter, Bact-hme Hme/filter And Bact-hme Midi Hme/filter.

Pre-market Notification Details

Device IDK202459
510k NumberK202459
Device Name:Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter And Bact-HME Midi HME/Filter
ClassificationFilter, Bacterial, Breathing-circuit
Applicant Pharma System AB Rubanksgatan 9 Knivsta,  SE 74171
ContactViljar Salumaa
CorrespondentScott Blood
MEDIcept Inc. 200 Homer Ave Ashland,  MA  01721
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-27
Decision Date2021-09-26

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