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FDA 510(k)

Keeler TonoCare Tonometer

K-Number: K181143 · 2019-02-08

ApplicantKeeler Instruments, Inc.
Decision Date2019-02-08
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Keeler TonoCare Tonometer is a medical device manufactured by Keeler Instruments, Inc.. It received FDA 510(k) clearance on 2019-02-08 under approval number K181143. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Keeler TonoCare Tonometer?

Keeler TonoCare Tonometer is a medical device that received FDA 510(k) clearance on 2019-02-08. It is manufactured by Keeler Instruments, Inc.. The 510(k) number is K181143.

When was Keeler TonoCare Tonometer approved by the FDA?

Keeler TonoCare Tonometer received FDA 510(k) clearance on 2019-02-08, under approval number K181143.

What company makes Keeler TonoCare Tonometer?

Keeler TonoCare Tonometer is manufactured by Keeler Instruments, Inc..

What is the FDA product code for Keeler TonoCare Tonometer?

The FDA product code for Keeler TonoCare Tonometer is HKX.

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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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