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FDA 510(k)

VERSABOARD, MODEL 7040

K-Number: K030051 · 2003-04-04

ApplicantBionix Development Corp.
Decision Date2003-04-04
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VERSABOARD, MODEL 7040 is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corp.. It received FDA 510(k) clearance on 2003-04-04 under 510(k) number K030051. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSABOARD, MODEL 7040?

VERSABOARD, MODEL 7040 is a medical device that received FDA 510(k) clearance on 2003-04-04. The listed applicant is Bionix Development Corp.. The 510(k) number is K030051.

When did VERSABOARD, MODEL 7040 receive FDA 510(k) clearance?

VERSABOARD, MODEL 7040 received FDA 510(k) clearance on 2003-04-04, under 510(k) number K030051.

Who is the listed applicant for VERSABOARD, MODEL 7040?

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

What is the FDA product code for VERSABOARD, MODEL 7040?

The FDA product code for VERSABOARD, MODEL 7040 is IYE.

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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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