BIRTHTRACK— 510(k) K080672

Substantially Equivalent

Barnev, Ltd.

FDA 510(k) clearance K080672 for BIRTHTRACK, Substantially Equivalent on 2008-07-08. Applicant: Barnev, Ltd.. Device class: 2.

Clearance details

Applicant: Barnev, Ltd.
Product code: Code NPB
Device class: Class 2
Regulation: 21 CFR 884.2800
Advisory panel: Ophthalmic
Date received: 2008-03-10
Decision date: 2008-07-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Kfar Saba, 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.