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FDA 510(k)

FREEDOM TRAVELLER

K-Number: K964825 · 1997-05-19

ApplicantImpact Case Technologies, Inc.
Decision Date1997-05-19
Product CodeMLW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FREEDOM TRAVELLER is the device name listed in this FDA 510(k) record. The listed applicant is Impact Case Technologies, Inc.. It received FDA 510(k) clearance on 1997-05-19 under 510(k) number K964825. The device is classified under product code MLW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREEDOM TRAVELLER?

FREEDOM TRAVELLER is a medical device that received FDA 510(k) clearance on 1997-05-19. The listed applicant is Impact Case Technologies, Inc.. The 510(k) number is K964825.

When did FREEDOM TRAVELLER receive FDA 510(k) clearance?

FREEDOM TRAVELLER received FDA 510(k) clearance on 1997-05-19, under 510(k) number K964825.

Who is the listed applicant for FREEDOM TRAVELLER?

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

What is the FDA product code for FREEDOM TRAVELLER?

The FDA product code for FREEDOM TRAVELLER is MLW.

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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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