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FDA 510(k)

TONO-PEN TONOMETER TIP COVER

K-Number: K033146 · 2004-11-23

ApplicantTra & Accessories
Decision Date2004-11-23
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TONO-PEN TONOMETER TIP COVER is the device name listed in this FDA 510(k) record. The listed applicant is Tra & Accessories. It received FDA 510(k) clearance on 2004-11-23 under 510(k) number K033146. 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 TONOMETER TIP COVER?

TONO-PEN TONOMETER TIP COVER is a medical device that received FDA 510(k) clearance on 2004-11-23. The listed applicant is Tra & Accessories. The 510(k) number is K033146.

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

TONO-PEN TONOMETER TIP COVER received FDA 510(k) clearance on 2004-11-23, under 510(k) number K033146.

Who is the listed applicant for TONO-PEN TONOMETER TIP COVER?

The FDA 510(k) record lists Tra & Accessories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TONO-PEN TONOMETER TIP COVER?

The FDA product code for TONO-PEN TONOMETER TIP COVER is HKY.

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Related Devices (Code: HKY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241447iCare ST500 (TA04)Icare Finland OYK233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.K234037CATS-L Tonometer™ PrismCats Tonometer, LLCK232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare IC200Icare Finland OYK211355iCare HOME2Icare Finland OY

Official Source

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

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