iVitri EZ— 510(k) K162640

Substantially Equivalent

Reprobitech Corp.

FDA 510(k) clearance K162640 for iVitri EZ, Substantially Equivalent on 2017-06-30. Applicant: Reprobitech Corp.. Device class: 2.

Clearance details

Applicant: Reprobitech Corp.
Product code: Product code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
Advisory panel: Obstetrics/Gynecology
Date received: 2016-09-22
Decision date: 2017-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Hyde Park, NY, 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.