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FDA 510(k)

VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000

K-Number: K901602 · 1990-05-07

ApplicantResonex, Inc.
Decision Date1990-05-07
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000 is the device name listed in this FDA 510(k) record. The listed applicant is Resonex, Inc.. It received FDA 510(k) clearance on 1990-05-07 under 510(k) number K901602. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000?

VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000 is a medical device that received FDA 510(k) clearance on 1990-05-07. The listed applicant is Resonex, Inc.. The 510(k) number is K901602.

When did VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000 receive FDA 510(k) clearance?

VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000 received FDA 510(k) clearance on 1990-05-07, under 510(k) number K901602.

Who is the listed applicant for VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000?

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

What is the FDA product code for VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000?

The FDA product code for VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000 is LNH.

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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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