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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Pulse Biosciences, Inc.. It received FDA 510(k) clearance on 2022-09-22 under 510(k) 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. The listed applicant is Pulse Biosciences, Inc.. The 510(k) number is K213674.

When did CellFX System receive FDA 510(k) clearance?

CellFX System received FDA 510(k) clearance on 2022-09-22, under 510(k) number K213674.

Who is the listed applicant for CellFX System?

The FDA 510(k) record lists Pulse Biosciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CellFX System?

The FDA product code for CellFX System is GEI.

Other records listing Pulse Biosciences, Inc. as applicant

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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.

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