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FDA 510(k)

DIGITAL INFLECTION RIGIDOMETER (DIR)

K-Number: K000194 · 2000-04-10

ApplicantUroan Xxi Electromedicina
Decision Date2000-04-10
Product CodeLIL
DecisionSubstantially Equivalent

Device Summary

DIGITAL INFLECTION RIGIDOMETER (DIR) is the device name listed in this FDA 510(k) record. The listed applicant is Uroan Xxi Electromedicina. It received FDA 510(k) clearance on 2000-04-10 under 510(k) number K000194. The device is classified under product code LIL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL INFLECTION RIGIDOMETER (DIR)?

DIGITAL INFLECTION RIGIDOMETER (DIR) is a medical device that received FDA 510(k) clearance on 2000-04-10. The listed applicant is Uroan Xxi Electromedicina. The 510(k) number is K000194.

When did DIGITAL INFLECTION RIGIDOMETER (DIR) receive FDA 510(k) clearance?

DIGITAL INFLECTION RIGIDOMETER (DIR) received FDA 510(k) clearance on 2000-04-10, under 510(k) number K000194.

Who is the listed applicant for DIGITAL INFLECTION RIGIDOMETER (DIR)?

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

What is the FDA product code for DIGITAL INFLECTION RIGIDOMETER (DIR)?

The FDA product code for DIGITAL INFLECTION RIGIDOMETER (DIR) is LIL.

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

Related Devices (Code: LIL)

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.

K061676RIGIDOMETER, MODEL DIR-4UUroan 21K062042PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)Plethora SolutionsK052929PREFTEST PROFESSIONAL SUITELimestone Technologies, Inc.K033126MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEMBehavioral Technology, Inc.K991479VISER PENILE TUMESCENCE MONITORLaborie Medical Tech Corp.K980627NEVA SYSTEMUrometrics, Inc.

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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