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FDA 510(k)

IRV2000 INDIVIDUAL RECREATIONAL VEHICLE

K-Number: K001835 · 2000-10-11

ApplicantTrac About, Inc.
Decision Date2000-10-11
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IRV2000 INDIVIDUAL RECREATIONAL VEHICLE is the device name listed in this FDA 510(k) record. The listed applicant is Trac About, Inc.. It received FDA 510(k) clearance on 2000-10-11 under 510(k) number K001835. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRV2000 INDIVIDUAL RECREATIONAL VEHICLE?

IRV2000 INDIVIDUAL RECREATIONAL VEHICLE is a medical device that received FDA 510(k) clearance on 2000-10-11. The listed applicant is Trac About, Inc.. The 510(k) number is K001835.

When did IRV2000 INDIVIDUAL RECREATIONAL VEHICLE receive FDA 510(k) clearance?

IRV2000 INDIVIDUAL RECREATIONAL VEHICLE received FDA 510(k) clearance on 2000-10-11, under 510(k) number K001835.

Who is the listed applicant for IRV2000 INDIVIDUAL RECREATIONAL VEHICLE?

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

What is the FDA product code for IRV2000 INDIVIDUAL RECREATIONAL VEHICLE?

The FDA product code for IRV2000 INDIVIDUAL RECREATIONAL VEHICLE is INI.

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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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