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510(k) K132186

OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 by Optomed OY — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2013
Date Received
July 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

Other clearances by Optomed OY

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  • K163021 — HAAG-STREIT FUNDUS MODULE 300 (April 11, 2017)
  • K110986 — OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 (May 16, 2011)
  • K092056 — OPTOMED SMARTSCOPE, MODEL M3-1 EY1 (October 1, 2009)
  • K990417 — DERMACOOL (April 14, 1999)
  • K923531 — OPTOSCALPEL I LASER SYSTEM (November 12, 1993)

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