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FDA 510(k)

REFLEX EGR

K-Number: K940955 · 1994-06-02

ApplicantRicard-Allan Medical
Decision Date1994-06-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REFLEX EGR is the device name listed in this FDA 510(k) record. The listed applicant is Ricard-Allan Medical. It received FDA 510(k) clearance on 1994-06-02 under 510(k) number K940955. 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 REFLEX EGR?

REFLEX EGR is a medical device that received FDA 510(k) clearance on 1994-06-02. The listed applicant is Ricard-Allan Medical. The 510(k) number is K940955.

When did REFLEX EGR receive FDA 510(k) clearance?

REFLEX EGR received FDA 510(k) clearance on 1994-06-02, under 510(k) number K940955.

Who is the listed applicant for REFLEX EGR?

The FDA 510(k) record lists Ricard-Allan Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFLEX EGR?

The FDA product code for REFLEX EGR is GEI.

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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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