Icare HOME tonometer— 510(k) K163343

Substantially Equivalent

Icare Finland OY

FDA 510(k) clearance K163343 for Icare HOME tonometer, Substantially Equivalent on 2017-03-21. Applicant: Icare Finland OY.

Clearance details

Applicant: Icare Finland OY
Product code: Code HKY
Advisory panel: Ophthalmic
Date received: 2016-11-29
Decision date: 2017-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vantaa, FI

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