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FDA 510(k)

REDTECH GIPC 2000

K-Number: K004040 · 2001-03-29

ApplicantRed-Tech, Inc.
Decision Date2001-03-29
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REDTECH GIPC 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Red-Tech, Inc.. It received FDA 510(k) clearance on 2001-03-29 under 510(k) number K004040. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDTECH GIPC 2000?

REDTECH GIPC 2000 is a medical device that received FDA 510(k) clearance on 2001-03-29. The listed applicant is Red-Tech, Inc.. The 510(k) number is K004040.

When did REDTECH GIPC 2000 receive FDA 510(k) clearance?

REDTECH GIPC 2000 received FDA 510(k) clearance on 2001-03-29, under 510(k) number K004040.

Who is the listed applicant for REDTECH GIPC 2000?

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

What is the FDA product code for REDTECH GIPC 2000?

The FDA product code for REDTECH GIPC 2000 is FFX.

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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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