E-Cath STIM Acc. Tsui

Anesthesia Conduction Kit

PAJUNK GmbH Medizintechnologie

The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for E-cath Stim Acc. Tsui.

Pre-market Notification Details

Device IDK202699
510k NumberK202699
Device Name:E-Cath STIM Acc. Tsui
ClassificationAnesthesia Conduction Kit
Applicant PAJUNK GmbH Medizintechnologie Karl-Hall-Str 1 Geisingen,  DE 78187
ContactChristian G.h. Quass
CorrespondentChristian G.h. Quass
PAJUNK GmbH Medizintechnologie Karl-Hall-Str. 1 Geisingen,  DE 78187
Product CodeCAZ  
Subsequent Product CodeBSO
Subsequent Product CodeBSP
CFR Regulation Number868.5140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-16
Decision Date2020-12-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048223092842 K202699 000
04048223070604 K202699 000

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