Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)— 510(k) K233516

Name: FDA 510(k) clearance K233516
Creator: U.S. Food and Drug Administration
Published: 2024-05-01

Substantially Equivalent

Reichert, Inc.

FDA 510(k) clearance K233516 for Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318), Substantially Equivalent on 2024-05-01. Applicant: Reichert, Inc.. Device class: 2.

Clearance details

Applicant: Reichert, Inc.
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2023-11-01
Decision date: 2024-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Depew, NY, US

Download summary PDF View on FDA.gov ↗

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