GWY — Pinwheel Class I

FDA Device Classification

Classification Details

Product Code
GWY
Device Class
Class I
Regulation Number
882.1750
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K050313aspect medical systemsBIS SRS (SEMI-RESUABLE SENSOR)February 24, 2005
K942926burke neutechNEURO-AIDEAugust 3, 1994
K871167dexin pty.SENSITESTERApril 1, 1987
K851749artiberia1-380 PINWHEEL (WARTENBERG)June 13, 1985
K780422projects in healthPINWHEELApril 4, 1978