FDA 510(k)

P200T

K-Number: K111628 · 2011-08-19

Decision Date2011-08-19

Product CodeMYC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

P200T is the device name listed in this FDA 510(k) record. The listed applicant is Optos Plc.. It received FDA 510(k) clearance on 2011-08-19 under 510(k) number K111628. 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 P200T?

P200T is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Optos Plc.. The 510(k) number is K111628.

When did P200T receive FDA 510(k) clearance?

P200T received FDA 510(k) clearance on 2011-08-19, under 510(k) number K111628.

Who is the listed applicant for P200T?

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 P200T?

The FDA product code for P200T is MYC.

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)K190732P200TxE K173707P200TE K162039OptosAdvance 4.0 Software K121043OPTOS OCT/SLO MICROPERIMETER

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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.