TOCO LITE, MODEL TD-01— 510(k) K013477

Substantially Equivalent

Ventrex, Inc.

FDA 510(k) clearance K013477 for TOCO LITE, MODEL TD-01, Substantially Equivalent on 2002-01-17. Applicant: Ventrex, Inc.. Device class: 2.

Clearance details

Applicant: Ventrex, Inc.
Product code: Code HFM
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 2001-10-19
Decision date: 2002-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, 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.