FDA.report

510(k) K233602

Device
P200TE (A10700)
Applicant
Optos Plc.
510(k) number
K233602
Product code
OBO
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-09
Date received
2023-11-09
Regulation
886.1570
Classification name
Tomography, Optical Coherence
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Graham McLeod
Address
Queensferry House Carnegie Campus, Enterprise Way Dunfermline GB KY11 8GR KY11 8GR

FDA Registration Numbers

Source Documents

510(k) summary PDF

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