CellFX System
K-Number: K203299 · 2021-02-02
ApplicantPulse Biosciences, Inc.
Decision Date2021-02-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
CellFX System is a medical device manufactured by Pulse Biosciences, Inc.. It received FDA 510(k) clearance on 2021-02-02 under approval number K203299. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CellFX System?
CellFX System is a medical device that received FDA 510(k) clearance on 2021-02-02. It is manufactured by Pulse Biosciences, Inc.. The 510(k) number is K203299.
When was CellFX System approved by the FDA?
CellFX System received FDA 510(k) clearance on 2021-02-02, under approval number K203299.
What company makes CellFX System?
CellFX System is manufactured by Pulse Biosciences, Inc..
What is the FDA product code for CellFX System?
The FDA product code for CellFX System is GEI.
Related Clinical Trials
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.