← FDA Medical Device Classifications

Headrest, Neurosurgical

HBM · Class I — Low Risk (general controls) · Neurology · 21 CFR 882.4440

Classification

FDA Product Code
HBM
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 882.4440
Review panel
NE
Medical specialty
Neurology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
3
Registered establishments
32

Source

Authoritative
FDA Device Classification database
Machine
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