FDA 510(k)

T-GUARD

K-Number: K945537 · 1995-03-23

Decision Date1995-03-23

Product CodeLQX

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

T-GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Med ET AL Development. It received FDA 510(k) clearance on 1995-03-23 under 510(k) number K945537. The device is classified under product code LQX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-GUARD?

T-GUARD is a medical device that received FDA 510(k) clearance on 1995-03-23. The listed applicant is Med ET AL Development. The 510(k) number is K945537.

When did T-GUARD receive FDA 510(k) clearance?

T-GUARD received FDA 510(k) clearance on 1995-03-23, under 510(k) number K945537.

Who is the listed applicant for T-GUARD?

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

What is the FDA product code for T-GUARD?

The FDA product code for T-GUARD is LQX.

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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.