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510(k) K151491

Falck Medical Multifunction Tonometer, FAT1 by Falck Medical, Inc. — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2016
Date Received
June 3, 2015
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 Falck Medical, Inc.

  • K071755 — FALCK APPLANATION TONOMETER (FAT2) (June 3, 2008)

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  • K191314 — Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q (December 19, 2019)