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FDA 510(k)

OPTOS LIMITED PANORAMIC 200CAF

K-Number: K100644 · 2010-07-15

ApplicantOptos Plc.
Decision Date2010-07-15
Product CodeMYC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTOS LIMITED PANORAMIC 200CAF is the device name listed in this FDA 510(k) record. The listed applicant is Optos Plc.. It received FDA 510(k) clearance on 2010-07-15 under 510(k) number K100644. The device is classified under product code MYC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTOS LIMITED PANORAMIC 200CAF?

OPTOS LIMITED PANORAMIC 200CAF is a medical device that received FDA 510(k) clearance on 2010-07-15. The listed applicant is Optos Plc.. The 510(k) number is K100644.

When did OPTOS LIMITED PANORAMIC 200CAF receive FDA 510(k) clearance?

OPTOS LIMITED PANORAMIC 200CAF received FDA 510(k) clearance on 2010-07-15, under 510(k) number K100644.

Who is the listed applicant for OPTOS LIMITED PANORAMIC 200CAF?

The FDA 510(k) record lists Optos Plc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTOS LIMITED PANORAMIC 200CAF?

The FDA product code for OPTOS LIMITED PANORAMIC 200CAF is MYC.

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Other records listing Optos Plc. 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.

K233602P200TE (A10700)K231673P200TE (A10700)K190732P200TxEK173707P200TEK162039OptosAdvance 4.0 SoftwareK121043OPTOS OCT/SLO MICROPERIMETER

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Related Devices (Code: MYC)

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.

K261255KOWA FM-600Kowa Company, Ltd. Chofu FactoryK241931OcuMet Beacon (OCUB100)Ocusciences, Inc.K243504MAIA (AHMACME001)Centervue S.P.A.K213705DRSplusCentervue S.P.A.K211328EIDON FA, EIDON, EIDON AF, EIDON UWFLCentervue S.P.A.K192113DRSplusCentervue S.P.A.

Official Source

View on FDA Database →

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

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