Shape-HF Cardiopulmonary Testing System— 510(k) K150888

Name: FDA 510(k) clearance K150888
Creator: U.S. Food and Drug Administration
Published: 2016-01-21

Substantially Equivalent

Shape Medical Systems, Inc.

FDA 510(k) clearance K150888 for Shape-HF Cardiopulmonary Testing System, Substantially Equivalent on 2016-01-21. Applicant: Shape Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Shape Medical Systems, Inc.
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2015-04-02
Decision date: 2016-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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