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FDA 510(k)

FALCK APPLANATION TONOMETER (FAT2)

K-Number: K071755 · 2008-06-03

ApplicantFalck Medical, Inc.
Decision Date2008-06-03
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FALCK APPLANATION TONOMETER (FAT2) is the device name listed in this FDA 510(k) record. The listed applicant is Falck Medical, Inc.. It received FDA 510(k) clearance on 2008-06-03 under 510(k) number K071755. 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 FALCK APPLANATION TONOMETER (FAT2)?

FALCK APPLANATION TONOMETER (FAT2) is a medical device that received FDA 510(k) clearance on 2008-06-03. The listed applicant is Falck Medical, Inc.. The 510(k) number is K071755.

When did FALCK APPLANATION TONOMETER (FAT2) receive FDA 510(k) clearance?

FALCK APPLANATION TONOMETER (FAT2) received FDA 510(k) clearance on 2008-06-03, under 510(k) number K071755.

Who is the listed applicant for FALCK APPLANATION TONOMETER (FAT2)?

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

What is the FDA product code for FALCK APPLANATION TONOMETER (FAT2)?

The FDA product code for FALCK APPLANATION TONOMETER (FAT2) 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 Falck Medical, Inc. 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.

K151491Falck Medical Multifunction Tonometer, FAT1

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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