EMBRACE— 510(k) K101373

Substantially Equivalent

Izi Medical Products, Inc.

FDA 510(k) clearance K101373 for EMBRACE, Substantially Equivalent on 2010-09-15. Applicant: Izi Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Izi Medical Products, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2010-05-17
Decision date: 2010-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, 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.