CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA— 510(k) K051940

Name: FDA 510(k) clearance K051940
Creator: U.S. Food and Drug Administration
Published: 2005-09-28

Substantially Equivalent

Sis Ltd., Surgical Instrument Systems

FDA 510(k) clearance K051940 for CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA, Substantially Equivalent on 2005-09-28. Applicant: Sis Ltd., Surgical Instrument Systems. Device class: 2.

Clearance details

Applicant: Sis Ltd., Surgical Instrument Systems
Product code: Code MXK
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2005-07-18
Decision date: 2005-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

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