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510(k) K182491

Applanation tonometer AT-2 by Takagi Seiko Co., Ltd. — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2018
Date Received
September 11, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Manual
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

Other clearances by Takagi Seiko Co., Ltd.

  • K172728 — Applanation tonometer AT-1 (October 17, 2017)
  • K162636 — Marco Ultra M3, Marco Ultra M4 (April 14, 2017)
  • K152535 — Z5 Slit lamp microscope, Z2 Slit lamp microscope (May 26, 2016)
  • K063352 — ELLEX SLIT LAMP, MODEL 30XL (March 13, 2007)

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