meddevicedb.com FDA Device Reference

FDA Product Code

FDA Product Code NPB — Clearance Directory

Device Class
Class II
Assigned Panel
Ophthalmic
21 CFR Citation
884.2800

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K081984 LABORPRO SYSTEM Trig Medical, Ltd. 2009-03-04 Traditional PDF ↗
K082704 BIRTHTRACK (A.K.A. CLM) Barnev, Ltd. 2009-01-09 Traditional PDF ↗
K080672 BIRTHTRACK Barnev, Ltd. 2008-07-08 Special PDF ↗
DEN060006 COMPUTERIZED LABOR MONITORING SYSTEM Barnev, Ltd. 2007-01-30 Post-NSE —

Product code NPB · Class II · Ophthalmic. Data: openFDA.