FDA 510(k)

TBI TRAINER

K-Number: K840837 · 1985-03-25

ApplicantManico

Decision Date1985-03-25

Product CodeFEJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

TBI TRAINER is the device name listed in this FDA 510(k) record. The listed applicant is Manico. It received FDA 510(k) clearance on 1985-03-25 under 510(k) number K840837. The device is classified under product code FEJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBI TRAINER?

TBI TRAINER is a medical device that received FDA 510(k) clearance on 1985-03-25. The listed applicant is Manico. The 510(k) number is K840837.

When did TBI TRAINER receive FDA 510(k) clearance?

TBI TRAINER received FDA 510(k) clearance on 1985-03-25, under 510(k) number K840837.

Who is the listed applicant for TBI TRAINER?

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

What is the FDA product code for TBI TRAINER?

The FDA product code for TBI TRAINER is FEJ.

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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.