INFREX— 510(k) K060246

Substantially Equivalent

Johari Digital Healthcare , Ltd.

FDA 510(k) clearance K060246 for INFREX, Substantially Equivalent on 2006-05-05. Applicant: Johari Digital Healthcare , Ltd.. Device class: 2.

Clearance details

Applicant: Johari Digital Healthcare , Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2006-01-31
Decision date: 2006-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canoga Park, 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.