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FDA 510(k)

TEEN 100

K-Number: K945213 · 1995-05-25

ApplicantAerosport, Inc.
Decision Date1995-05-25
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TEEN 100 is the device name listed in this FDA 510(k) record. The listed applicant is Aerosport, Inc.. It received FDA 510(k) clearance on 1995-05-25 under 510(k) number K945213. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEEN 100?

TEEN 100 is a medical device that received FDA 510(k) clearance on 1995-05-25. The listed applicant is Aerosport, Inc.. The 510(k) number is K945213.

When did TEEN 100 receive FDA 510(k) clearance?

TEEN 100 received FDA 510(k) clearance on 1995-05-25, under 510(k) number K945213.

Who is the listed applicant for TEEN 100?

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

What is the FDA product code for TEEN 100?

The FDA product code for TEEN 100 is BZC.

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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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