P200DTx
FDA 510(k) K142897 · Optos Plc.
510(k) numberK142897
Submission
- Device name
- P200DTx
- Applicant
- Optos Plc.
Dunfermline, GB - Received
- October 3, 2014
- Decision date
- January 16, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MYC – Ophthalmoscope, Laser, Scanning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1570
- Specialty
- Ophthalmic
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More from Centervue S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K233602 | P200TE (A10700)OBO · Traditional | 05/09/2024SE |
| K231673 | P200TE (A10700)OBO · Traditional | 08/18/2023SE |
| K190732 | P200TxEOBO · Traditional | 07/31/2019SE |
| K173707 | P200TEOBO · Traditional | 02/28/2018SE |
| K162039 | OptosAdvance 4.0 SoftwareNFJ · Traditional | 02/08/2017SE |
| K134039 | Daytona Icg (P200TICG)MYC · Traditional | 04/11/2014SE |
| K121043 | Optos Oct/Slo MicroperimeterOBO · Traditional | 02/22/2013SE |
| K113696 | Optos AdvanceNFJ · Traditional | 05/25/2012SE |
| K111628 | P200TMYC · Special | 08/19/2011SE |
| K102492 | P200MAAFMYC · Special | 09/30/2010SE |
Questions and answers
When was P200DTx cleared by the FDA?
P200DTx (K142897) received a 510(k) decision of Substantially Equivalent on January 16, 2015, 105 days after the submission was received.
What is the product code of K142897?
The FDA product code is MYC – Ophthalmoscope, Laser, Scanning, a Class II (moderate risk) device regulated under 21 CFR 886.1570.