Radial Medical Compression System— 510(k) K190976

Name: FDA 510(k) clearance K190976
Creator: U.S. Food and Drug Administration
Published: 2019-07-12

Substantially Equivalent

Radial Medical, Inc.

FDA 510(k) clearance K190976 for Radial Medical Compression System, Substantially Equivalent on 2019-07-12. Applicant: Radial Medical, Inc.. Device class: 2.

Clearance details

Applicant: Radial Medical, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2019-04-15
Decision date: 2019-07-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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