TEEN 100— 510(k) K945213

Substantially Equivalent

Aerosport, Inc.

FDA 510(k) clearance K945213 for TEEN 100, Substantially Equivalent on 1995-05-25. Applicant: Aerosport, Inc.. Device class: 2.

Clearance details

Applicant: Aerosport, Inc.
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 1994-10-25
Decision date: 1995-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.