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FDA 510(k)

REDOX CONTROLLER

K-Number: K830994 · 1983-05-27

ApplicantSt. Louis Univ. Medical Center
Decision Date1983-05-27
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REDOX CONTROLLER is the device name listed in this FDA 510(k) record. The listed applicant is St. Louis Univ. Medical Center. It received FDA 510(k) clearance on 1983-05-27 under 510(k) number K830994. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDOX CONTROLLER?

REDOX CONTROLLER is a medical device that received FDA 510(k) clearance on 1983-05-27. The listed applicant is St. Louis Univ. Medical Center. The 510(k) number is K830994.

When did REDOX CONTROLLER receive FDA 510(k) clearance?

REDOX CONTROLLER received FDA 510(k) clearance on 1983-05-27, under 510(k) number K830994.

Who is the listed applicant for REDOX CONTROLLER?

The FDA 510(k) record lists St. Louis Univ. Medical Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REDOX CONTROLLER?

The FDA product code for REDOX CONTROLLER is KDN.

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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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