TRANSONIC HCM 103 SYSTEM— 510(k) K134035

Name: FDA 510(k) clearance K134035
Creator: U.S. Food and Drug Administration
Published: 2014-09-17

Substantially Equivalent

Transonic Systems, Inc.

FDA 510(k) clearance K134035 for TRANSONIC HCM 103 SYSTEM, Substantially Equivalent on 2014-09-17. 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: 2014-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ithaca, NY, US

Download summary PDF View on FDA.gov ↗

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