CM 3910 Rotating Double Scheimpflug Camera

FDA 510(k) K051940 · Sis Ltd., Surgical Instrument Systems

Substantially Equivalent

510(k) numberK051940

Submission

Device name
CM 3910 Rotating Double Scheimpflug Camera
Applicant
Sis Ltd., Surgical Instrument Systems
Littleton, CO, US
Received
July 18, 2005
Decision date
September 28, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MXK – Device, Analysis, Anterior Segment
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1850
Specialty
Ophthalmic

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Questions and answers

When was CM 3910 Rotating Double Scheimpflug Camera cleared by the FDA?

CM 3910 Rotating Double Scheimpflug Camera (K051940) received a 510(k) decision of Substantially Equivalent on September 28, 2005, 72 days after the submission was received.

What is the product code of K051940?

The FDA product code is MXK – Device, Analysis, Anterior Segment, a Class II (moderate risk) device regulated under 21 CFR 886.1850.