BABYCOM— 510(k) K013547

Substantially Equivalent

Pmg Medica , Ltd.

FDA 510(k) clearance K013547 for BABYCOM, Substantially Equivalent on 2002-02-20. Applicant: Pmg Medica , Ltd.. Device class: 2.

Clearance details

Applicant: Pmg Medica , Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2001-10-24
Decision date: 2002-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Efrat, IL

Download summary PDF View on FDA.gov ↗

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