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510(k) K181260

MiiS Horus Scope DPT 100 by Medimaging Integrated Solution, Inc (Miis) — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2019
Date Received
May 11, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

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Other clearances for product code HKX

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  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • K180820 — Tono Vue Non-Contact Tonometer (December 14, 2018)
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  • K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (December 10, 2010)