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FDA 510(k)

SENORX ES-300

K-Number: K030473 · 2003-02-26

ApplicantSenorx, Inc.
Decision Date2003-02-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SENORX ES-300 is the device name listed in this FDA 510(k) record. The listed applicant is Senorx, Inc.. It received FDA 510(k) clearance on 2003-02-26 under 510(k) number K030473. 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 SENORX ES-300?

SENORX ES-300 is a medical device that received FDA 510(k) clearance on 2003-02-26. The listed applicant is Senorx, Inc.. The 510(k) number is K030473.

When did SENORX ES-300 receive FDA 510(k) clearance?

SENORX ES-300 received FDA 510(k) clearance on 2003-02-26, under 510(k) number K030473.

Who is the listed applicant for SENORX ES-300?

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

What is the FDA product code for SENORX ES-300?

The FDA product code for SENORX ES-300 is GEI.

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Related Devices (Code: 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.

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