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FDA 510(k)

ICARE TONOMETER TA01I

K-Number: K063873 · 2007-05-23

ApplicantTiolat OY
Decision Date2007-05-23
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ICARE TONOMETER TA01I is the device name listed in this FDA 510(k) record. The listed applicant is Tiolat OY. It received FDA 510(k) clearance on 2007-05-23 under 510(k) number K063873. 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 ICARE TONOMETER TA01I?

ICARE TONOMETER TA01I is a medical device that received FDA 510(k) clearance on 2007-05-23. The listed applicant is Tiolat OY. The 510(k) number is K063873.

When did ICARE TONOMETER TA01I receive FDA 510(k) clearance?

ICARE TONOMETER TA01I received FDA 510(k) clearance on 2007-05-23, under 510(k) number K063873.

Who is the listed applicant for ICARE TONOMETER TA01I?

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

What is the FDA product code for ICARE TONOMETER TA01I?

The FDA product code for ICARE TONOMETER TA01I is HKY.

Related Clinical Trials

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.

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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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