TRANSONIC ELSA SYSTEM— 510(k) K134051

Substantially Equivalent

Transonic Systems, Inc.

FDA 510(k) clearance K134051 for TRANSONIC ELSA SYSTEM, Substantially Equivalent on 2015-01-29. Applicant: Transonic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Transonic Systems, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2013-12-31
Decision date: 2015-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ithaca, NY, 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.