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510(k) K232273

RM Electrode (RMH 23-01) by Retmap, Inc. — Product Code HLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2023
Date Received
July 31, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Corneal
Device Class
Class II
Regulation Number
886.1220
Review Panel
OP
Submission Type

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  • K820254 — GOLD FOIL ERG ELECTRODES (April 9, 1982)
  • K813399 — ERG-JET ELECTRODE (January 22, 1982)
  • K781476 — MULAR GOLD LEAF ELECTRODE MODEL 7501 (November 15, 1978)
  • K760199 — ELECTRORETINOGRAPH (August 4, 1976)