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TEEN 100

by Aerosport, Inc.

510(k) K945213

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945213 Date25 May 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BZC
Device Class
Class II
Regulation
21 CFR Part 868.1880
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The TEEN 100 is a calculator for pulmonary function data. It is a Class II medical device used for processing and calculating pulmonary function measurements.

The TEEN 100 is manufactured by Aerosport, Inc. and received FDA 510(k) clearance on May 25, 1995. It is authorized under product code BZC and is intended for use in anesthesiology settings. The device is supplied with various model numbers and registration numbers as specified in the authorizations.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the TEEN 100 device used for?

    The TEEN 100 is a calculator specifically designed for processing and calculating pulmonary function data. It is intended for use in anesthesiology settings to assist with pulmonary function measurements.

  • Is the TEEN 100 a single-use or reusable device?

    The device data does not specify whether the TEEN 100 is single-use or reusable. As a calculator for pulmonary function data, it appears to be a device that would be used multiple times in clinical settings.

  • What are the regulatory details for the TEEN 100?

    The TEEN 100 received FDA 510(k) clearance on May 25, 1995, with product code BZC. It is classified as a Class II medical device and is authorized for use in anesthesiology settings. The device has multiple registration numbers as specified in the authorizations.

  • Who manufactures the TEEN 100 and where is it located?

    The TEEN 100 is manufactured by Aerosport, Inc., located at 3518 W. Liberty St., Ann Arbor, MI 48103, United States. The company contact is Andrew Raeder.