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FDA 510(k)

KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)

K-Number: K093445 · 2010-01-19

ApplicantKeeler, Ltd.
Decision Date2010-01-19
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) is the device name listed in this FDA 510(k) record. The listed applicant is Keeler, Ltd.. It received FDA 510(k) clearance on 2010-01-19 under 510(k) number K093445. 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 KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)?

KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) is a medical device that received FDA 510(k) clearance on 2010-01-19. The listed applicant is Keeler, Ltd.. The 510(k) number is K093445.

When did KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) receive FDA 510(k) clearance?

KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) received FDA 510(k) clearance on 2010-01-19, under 510(k) number K093445.

Who is the listed applicant for KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)?

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

What is the FDA product code for KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)?

The FDA product code for KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Keeler, Ltd. as applicant

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.

K131787CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBESK131589KEELER SLIT LAMP H-SERIES

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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