CellFX System
K-Number: K213674 · 2022-09-22
ApplicantPulse Biosciences, Inc.
Decision Date2022-09-22
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 2022-09-22 under approval number K213674. 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 2022-09-22. It is manufactured by Pulse Biosciences, Inc.. The 510(k) number is K213674.
When was CellFX System approved by the FDA?
CellFX System received FDA 510(k) clearance on 2022-09-22, under approval number K213674.
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.
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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.