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FDA 510(k)

CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA

K-Number: K051940 · 2005-09-28

ApplicantSis Ltd., Surgical Instrument Systems
Decision Date2005-09-28
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Sis Ltd., Surgical Instrument Systems. It received FDA 510(k) clearance on 2005-09-28 under 510(k) number K051940. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA?

CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA is a medical device that received FDA 510(k) clearance on 2005-09-28. The listed applicant is Sis Ltd., Surgical Instrument Systems. The 510(k) number is K051940.

When did CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA receive FDA 510(k) clearance?

CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA received FDA 510(k) clearance on 2005-09-28, under 510(k) number K051940.

Who is the listed applicant for CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA?

The FDA 510(k) record lists Sis Ltd., Surgical Instrument Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA?

The FDA product code for CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA is MXK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Sis Ltd., Surgical Instrument Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K082871XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MMK043150AMADEUS II EPIKERATOME

Related Devices (Code: MXK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251848Pentacam® Cornea OCTOculus Optikgeräte GmbHK252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey CorporationK223700BOSS™Intelon Optics, Inc.K222933MYAHVisia Imaging S.R.L.K211868MYAHVisia Imaging S.R.L.K202989Myopia MasterOculus Optikgeräte GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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