Renew NCP-5 External Counterpulsation System— 510(k) K152115

Name: FDA 510(k) clearance K152115
Creator: U.S. Food and Drug Administration
Published: 2015-12-17

Substantially Equivalent

Stage 2 Innovations

FDA 510(k) clearance K152115 for Renew NCP-5 External Counterpulsation System, Substantially Equivalent on 2015-12-17. Applicant: Stage 2 Innovations. Device class: 2.

Clearance details

Applicant: Stage 2 Innovations
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2015-07-29
Decision date: 2015-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, 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.