OVUSENSE— 510(k) K122337

Substantially Equivalent

Fertility Focus, Ltd.

FDA 510(k) clearance K122337 for OVUSENSE, Substantially Equivalent on 2013-08-06. Applicant: Fertility Focus, Ltd.. Device class: Unclassified.

Clearance details

Applicant: Fertility Focus, Ltd.
Product code: Code LHD
Device class: Unclassified
Advisory panel: Unknown
Date received: 2012-08-02
Decision date: 2013-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Swanee, GA, 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.