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FDA 510(k)

Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)

K-Number: K233516 · 2024-05-01

ApplicantReichert, Inc.
Decision Date2024-05-01
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) is a medical device manufactured by Reichert, Inc.. It received FDA 510(k) clearance on 2024-05-01 under approval number K233516. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)?

Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) is a medical device that received FDA 510(k) clearance on 2024-05-01. It is manufactured by Reichert, Inc.. The 510(k) number is K233516.

When was Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) approved by the FDA?

Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) received FDA 510(k) clearance on 2024-05-01, under approval number K233516.

What company makes Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)?

Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) is manufactured by Reichert, Inc..

What is the FDA product code for Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)?

The FDA product code for Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) is HKY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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