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FDA 510(k)

TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER

K-Number: K053430 · 2006-03-03

ApplicantMedtronic Xomed, Inc.
Decision Date2006-03-03
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2006-03-03 under 510(k) number K053430. 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-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER?

TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER is a medical device that received FDA 510(k) clearance on 2006-03-03. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K053430.

When did TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER receive FDA 510(k) clearance?

TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER received FDA 510(k) clearance on 2006-03-03, under 510(k) number K053430.

Who is the listed applicant for TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER?

The FDA 510(k) record lists Medtronic Xomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER?

The FDA product code for TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER 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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