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FDA 510(k)

P200TxE

K-Number: K190732 · 2019-07-31

ApplicantOptos Plc.
Decision Date2019-07-31
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

P200TxE is the device name listed in this FDA 510(k) record. The listed applicant is Optos Plc.. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K190732. 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 P200TxE?

P200TxE is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Optos Plc.. The 510(k) number is K190732.

When did P200TxE receive FDA 510(k) clearance?

P200TxE received FDA 510(k) clearance on 2019-07-31, under 510(k) number K190732.

Who is the listed applicant for P200TxE?

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 P200TxE?

The FDA product code for P200TxE is OBO.

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.

NCT05844852P200TE US Reference Database StudyCOMPLETEDNCT06269666P200TxE Diseased Eye Image CollectionCOMPLETED

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)K173707P200TEK162039OptosAdvance 4.0 Software

Related Devices (Code: OBO)

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.

K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbHK252633UNITY DX (UDX)Cylite Pty. , Ltd.K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey CorporationK250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbHK240924AnterionHeidelberg Engineering GmbHK241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH

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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