NeoNavia Biopsy System

Instrument, Biopsy

NeoDynamics AB

The following data is part of a premarket notification filed by Neodynamics Ab with the FDA for Neonavia Biopsy System.

Pre-market Notification Details

Device IDK220595
510k NumberK220595
Device Name:NeoNavia Biopsy System
ClassificationInstrument, Biopsy
Applicant NeoDynamics AB Lejonvagen 14 Lidingo,  SE SE-181 32
ContactAnna Forsberg
CorrespondentLeAnn Latham
M Squared Associates,Inc. 127 West 30th Street, 9th Floor New York,  NY  10001
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-01
Decision Date2022-09-08

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