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
Code MQK
Device class
Class 2
Regulation
21 CFR 884.6160
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New Hyde Park, NY, US
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