NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)— 510(k) K040913

Name: FDA 510(k) clearance K040913
Creator: U.S. Food and Drug Administration
Published: 2004-07-23

Substantially Equivalent

Bausch & Lomb

FDA 510(k) clearance K040913 for NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT), Substantially Equivalent on 2004-07-23. Applicant: Bausch & Lomb. Device class: 2.

Clearance details

Applicant: Bausch & Lomb
Product code: Code MXK
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2004-04-08
Decision date: 2004-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Dimas, CA, US

Download summary PDF View on FDA.gov ↗

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