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FDA Product Code

FDA Product Code GWY — Clearance Directory

Device Class
Class I
Assigned Panel
Neurology
21 CFR Citation
882.1750

510(k) Clearances — 5 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K050313 BIS SRS (SEMI-RESUABLE SENSOR) Aspect Medical Systems, Inc. 2005-02-24 Traditional PDF ↗
K942926 NEURO-AIDE Burke Neutech, Inc. 1994-08-03 Traditional PDF ↗
K871167 SENSITESTER Dexin Pty. , Ltd. 1987-04-01 Traditional PDF ↗
K851749 1-380 PINWHEEL (WARTENBERG) Artiberia 1985-06-13 Traditional PDF ↗
K780422 PINWHEEL Projects IN Health 1978-04-04 Traditional PDF ↗

Product code GWY · Class I · Neurology. Data: openFDA.