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FDA 510(k)

VISER PENILE TUMESCENCE MONITOR

K-Number: K991479 · 1999-07-07

ApplicantLaborie Medical Tech Corp.
Decision Date1999-07-07
Product CodeLIL
DecisionSubstantially Equivalent

Device Summary

VISER PENILE TUMESCENCE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Laborie Medical Tech Corp.. It received FDA 510(k) clearance on 1999-07-07 under 510(k) number K991479. The device is classified under product code LIL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISER PENILE TUMESCENCE MONITOR?

VISER PENILE TUMESCENCE MONITOR is a medical device that received FDA 510(k) clearance on 1999-07-07. The listed applicant is Laborie Medical Tech Corp.. The 510(k) number is K991479.

When did VISER PENILE TUMESCENCE MONITOR receive FDA 510(k) clearance?

VISER PENILE TUMESCENCE MONITOR received FDA 510(k) clearance on 1999-07-07, under 510(k) number K991479.

Who is the listed applicant for VISER PENILE TUMESCENCE MONITOR?

The FDA 510(k) record lists Laborie Medical Tech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISER PENILE TUMESCENCE MONITOR?

The FDA product code for VISER PENILE TUMESCENCE MONITOR 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

Other records listing Laborie Medical Tech Corp. 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.

K993721UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBESK990041UROSTYM BIOFEEDBACK AND STIMULATION PROBESK963064ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARMK950016CART, MODE NUMBER UDS-CART

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.K000194DIGITAL INFLECTION RIGIDOMETER (DIR)Uroan Xxi ElectromedicinaK980627NEVA SYSTEMUrometrics, Inc.

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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