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FDA 510(k)

CellFX® System

K-Number: K221671 · 2022-08-01

ApplicantPulse Biosciences, Inc.
Decision Date2022-08-01
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 2022-08-01 under 510(k) number K221671. 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 2022-08-01. The listed applicant is Pulse Biosciences, Inc.. The 510(k) number is K221671.

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

CellFX® System received FDA 510(k) clearance on 2022-08-01, under 510(k) number K221671.

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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