Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NOCTURNAL PENILE TUMESCENCE MONITOR

K-Number: K870983 · 1987-06-23

ApplicantTexas Medical Electronics Co.
Decision Date1987-06-23
Product CodeLIL
DecisionSubstantially Equivalent

Device Summary

NOCTURNAL PENILE TUMESCENCE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Texas Medical Electronics Co.. It received FDA 510(k) clearance on 1987-06-23 under 510(k) number K870983. The device is classified under product code LIL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOCTURNAL PENILE TUMESCENCE MONITOR?

NOCTURNAL PENILE TUMESCENCE MONITOR is a medical device that received FDA 510(k) clearance on 1987-06-23. The listed applicant is Texas Medical Electronics Co.. The 510(k) number is K870983.

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

NOCTURNAL PENILE TUMESCENCE MONITOR received FDA 510(k) clearance on 1987-06-23, under 510(k) number K870983.

Who is the listed applicant for NOCTURNAL PENILE TUMESCENCE MONITOR?

The FDA 510(k) record lists Texas Medical Electronics Co. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for NOCTURNAL 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

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 ElectromedicinaK991479VISER PENILE TUMESCENCE MONITORLaborie Medical Tech Corp.

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.

↑