CERVILENZ UTERINE MEASURING SOUND— 510(k) K011840

Name: FDA 510(k) clearance K011840
Creator: U.S. Food and Drug Administration
Published: 2001-08-10

Substantially Equivalent

Cervilenz, Inc.

FDA 510(k) clearance K011840 for CERVILENZ UTERINE MEASURING SOUND, Substantially Equivalent on 2001-08-10. Applicant: Cervilenz, Inc.. Device class: 1.

Clearance details

Applicant: Cervilenz, Inc.
Product code: Code HHM
Device class: Class 1
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2001-06-12
Decision date: 2001-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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