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FDA 510(k)

ADVENTURER

K-Number: K971142 · 1997-04-28

ApplicantT.E.S., Ltd.
Decision Date1997-04-28
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ADVENTURER is the device name listed in this FDA 510(k) record. The listed applicant is T.E.S., Ltd.. It received FDA 510(k) clearance on 1997-04-28 under 510(k) number K971142. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVENTURER?

ADVENTURER is a medical device that received FDA 510(k) clearance on 1997-04-28. The listed applicant is T.E.S., Ltd.. The 510(k) number is K971142.

When did ADVENTURER receive FDA 510(k) clearance?

ADVENTURER received FDA 510(k) clearance on 1997-04-28, under 510(k) number K971142.

Who is the listed applicant for ADVENTURER?

The FDA 510(k) record lists T.E.S., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVENTURER?

The FDA product code for ADVENTURER is IOR.

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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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