KOALA TOCO— 510(k) K140163

Substantially Equivalent

Clinical Innovations, LLC

FDA 510(k) clearance K140163 for KOALA TOCO, Substantially Equivalent on 2014-05-29. Applicant: Clinical Innovations, LLC. Device class: 2.

Clearance details

Applicant: Clinical Innovations, LLC
Product code: Code HFM
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 2014-01-22
Decision date: 2014-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, 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.