CellFX System

Electrosurgical, Cutting & Coagulation & Accessories

Pulse Biosciences, Inc.

The following data is part of a premarket notification filed by Pulse Biosciences, Inc. with the FDA for Cellfx System.

Pre-market Notification Details

Device IDK211444
510k NumberK211444
Device Name:CellFX System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Pulse Biosciences, Inc. 3957 Point Eden Way Hayward,  CA  94545
ContactPunam Gollamudi
CorrespondentPunam Gollamudi
Pulse Biosciences, Inc. 3957 Point Eden Way Hayward,  CA  94545
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-10
Decision Date2021-08-25

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