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510(k) K150320

COMPASS by Centervue S.P.A. — Product Code MYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2015
Date Received
February 9, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Laser, Scanning
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by Centervue S.P.A.

  • K243504 — MAIA (AHMACME001) (March 17, 2025)
  • K234076 — iCare ALTIUS CW (August 22, 2024)
  • K213705 — DRSplus (December 21, 2021)
  • K211328 — EIDON FA, EIDON, EIDON AF, EIDON UWFL (August 19, 2021)
  • K192113 — DRSplus (November 15, 2019)
  • K180526 — EIDON FA (July 16, 2018)
  • K180293 — Retia 2 (May 30, 2018)
  • K153181 — MAIA (June 8, 2016)
  • K142047 — EIDON (November 12, 2014)
  • K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT (April 23, 2014)

Other clearances for product code MYC

  • K241931 — OcuMet Beacon (OCUB100) (April 22, 2025)
  • K243504 — MAIA (AHMACME001) (March 17, 2025)
  • K213705 — DRSplus (December 21, 2021)
  • K211328 — EIDON FA, EIDON, EIDON AF, EIDON UWFL (August 19, 2021)
  • K192113 — DRSplus (November 15, 2019)
  • K180526 — EIDON FA (July 16, 2018)
  • K180293 — Retia 2 (May 30, 2018)
  • K153181 — MAIA (June 8, 2016)
  • K142897 — P200DTx (January 16, 2015)
  • K142047 — EIDON (November 12, 2014)