FDA 510(k)

AURAFLEX SYSTEMS

K-Number: K942443 · 1994-08-26

Decision Date1994-08-26

Product CodeJJE

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AURAFLEX SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1994-08-26 under 510(k) number K942443. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURAFLEX SYSTEMS?

AURAFLEX SYSTEMS is a medical device that received FDA 510(k) clearance on 1994-08-26. The listed applicant is Organon Teknika Corp.. The 510(k) number is K942443.

When did AURAFLEX SYSTEMS receive FDA 510(k) clearance?

AURAFLEX SYSTEMS received FDA 510(k) clearance on 1994-08-26, under 510(k) number K942443.

Who is the listed applicant for AURAFLEX SYSTEMS?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AURAFLEX SYSTEMS?

The FDA product code for AURAFLEX SYSTEMS is JJE.

Related Clinical Trials

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Other records listing Organon Teknika Corp. as applicant

K003104BACT/ALERT CSR K000492MDA D-DIMER K000378BACT/ALERT MB CULTURE BOTTLE K994343BACT/ALERT SV K993423BACT/ALERT SA K993421BACT/ALERT SN

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Related Devices (Code: JJE)

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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.