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510(k) K071755

FALCK APPLANATION TONOMETER (FAT2) by Falck Medical, Inc. — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2008
Date Received
June 28, 2007
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.

  • K151491 — Falck Medical Multifunction Tonometer, FAT1 (January 15, 2016)

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