HEART STG SYSTEM AND SOFTWARE— 510(k) K052283

Name: FDA 510(k) clearance K052283
Creator: U.S. Food and Drug Administration
Published: 2005-12-23

Substantially Equivalent

Stethographics, Inc.

FDA 510(k) clearance K052283 for HEART STG SYSTEM AND SOFTWARE, Substantially Equivalent on 2005-12-23. Applicant: Stethographics, Inc.. Device class: 2.

Clearance details

Applicant: Stethographics, Inc.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 2005-08-22
Decision date: 2005-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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