BIRTHTRACK (A.K.A. CLM)— 510(k) K082704

Substantially Equivalent

Barnev, Ltd.

FDA 510(k) clearance K082704 for BIRTHTRACK (A.K.A. CLM), Substantially Equivalent on 2009-01-09. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Kfar Saba, IL
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