ENDOMEDIX Y-ADAPTER— 510(k) K934170

Substantially Equivalent

Endomedix

FDA 510(k) clearance K934170 for ENDOMEDIX Y-ADAPTER, Substantially Equivalent on 1994-01-11. Applicant: Endomedix. Device class: 2.

Clearance details

Applicant: Endomedix
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1993-08-27
Decision date: 1994-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.