FDA 510(k)

P200TE (A10700)

K-Number: K233602 · 2024-05-09

Decision Date2024-05-09

Product CodeOBO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

P200TE (A10700) is a medical device manufactured by Optos Plc.. It received FDA 510(k) clearance on 2024-05-09 under approval number K233602. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P200TE (A10700)?

P200TE (A10700) is a medical device that received FDA 510(k) clearance on 2024-05-09. It is manufactured by Optos Plc.. The 510(k) number is K233602.

When was P200TE (A10700) approved by the FDA?

P200TE (A10700) received FDA 510(k) clearance on 2024-05-09, under approval number K233602.

What company makes P200TE (A10700)?

P200TE (A10700) is manufactured by Optos Plc..

What is the FDA product code for P200TE (A10700)?

The FDA product code for P200TE (A10700) is OBO.

Other Devices by Optos Plc.

K162039OptosAdvance 4.0 Software K173707P200TE K190732P200TxE K231673P200TE (A10700)

Related Devices (Code: OBO)

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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.