OEW · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4560
Classification
FDA Product Code
OEW
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.4560
Review panel
SU
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
Definition
For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.