PORTABLE NON-CONTACT TONOMETER, MODEL PT100— 510(k) K013259

Name: FDA 510(k) clearance K013259
Creator: U.S. Food and Drug Administration
Published: 2002-02-20

Substantially Equivalent

Leica Microsystems, Inc. O.I.D.

FDA 510(k) clearance K013259 for PORTABLE NON-CONTACT TONOMETER, MODEL PT100, Substantially Equivalent on 2002-02-20. Applicant: Leica Microsystems, Inc. O.I.D.. Device class: 2.

Clearance details

Applicant: Leica Microsystems, Inc. O.I.D.
Product code: Code HKX
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2001-10-01
Decision date: 2002-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Depew, NY, US

Download summary PDF View on FDA.gov ↗

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