NOCTURNAL PENILE TUMESCENCE MONITOR— 510(k) K870983

Name: FDA 510(k) clearance K870983
Creator: U.S. Food and Drug Administration
Published: 1987-06-23

Substantially Equivalent

Texas Medical Electronics Co.

FDA 510(k) clearance K870983 for NOCTURNAL PENILE TUMESCENCE MONITOR, Substantially Equivalent on 1987-06-23. Applicant: Texas Medical Electronics Co.. Device class: Unclassified.

Clearance details

Applicant: Texas Medical Electronics Co.
Product code: Code LIL
Device class: Unclassified
Advisory panel: Unknown
Date received: 1987-03-10
Decision date: 1987-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.