HBM — Headrest, Neurosurgical Class I

FDA Device Classification

FDA product code HBM covers "Headrest, Neurosurgical", a Class I medical device regulated under 21 CFR 882.4440. Submissions are reviewed by the Neurology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HBM
Device Class
Class I
Regulation Number
882.4440
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K911918codman and shurtleffSWIVEL HORSESHOE HEADRESTJuly 17, 1991
K911917codman and shurtleffCODMAN PEDIATRIC HORSESHOE HEADRESTJuly 17, 1991
K822169kelleherSURGICAL HEAD SUPPORTAugust 20, 1982