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FDA 510(k)

SHUNTCHECK (PROMETHEUS 1)

K-Number: K040021 · 2004-11-02

ApplicantSamuel Neff M.D.
Decision Date2004-11-02
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SHUNTCHECK (PROMETHEUS 1) is the device name listed in this FDA 510(k) record. The listed applicant is Samuel Neff M.D.. It received FDA 510(k) clearance on 2004-11-02 under 510(k) number K040021. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHUNTCHECK (PROMETHEUS 1)?

SHUNTCHECK (PROMETHEUS 1) is a medical device that received FDA 510(k) clearance on 2004-11-02. The listed applicant is Samuel Neff M.D.. The 510(k) number is K040021.

When did SHUNTCHECK (PROMETHEUS 1) receive FDA 510(k) clearance?

SHUNTCHECK (PROMETHEUS 1) received FDA 510(k) clearance on 2004-11-02, under 510(k) number K040021.

Who is the listed applicant for SHUNTCHECK (PROMETHEUS 1)?

The FDA 510(k) record lists Samuel Neff M.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHUNTCHECK (PROMETHEUS 1)?

The FDA product code for SHUNTCHECK (PROMETHEUS 1) is JXG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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