MONICA AN24— 510(k) K112390

Substantially Equivalent

Monica Healthcare, Ltd.

FDA 510(k) clearance K112390 for MONICA AN24, Substantially Equivalent on 2012-07-13. Applicant: Monica Healthcare, Ltd.. Device class: 2.

Clearance details

Applicant: Monica Healthcare, Ltd.
Product code: Code OSP
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 2011-08-18
Decision date: 2012-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nottingham, GB

Download summary PDF View on FDA.gov ↗

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