BXM — Stimulator, Nerve, Ac-Powered Class II

FDA Device Classification

Classification Details

Product Code
BXM
Device Class
Class II
Regulation Number
868.2775
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K013215nuvasiveMODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEMOctober 16, 2001
K002677nuvasiveNUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEMNovember 13, 2000
K921498vermont medicalVER MED A10011 PNS DUAL ELEMENT ELECTRODEJune 9, 1993
K870662life-tech intlMODEL SKCK STERILE KNOB COVER KITOctober 28, 1987