VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX


Device Classification Name

stimulator, nerve, electrial, percutaneous (pens), for pain relief

510(k) Number K022241
Device Name VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX
Original Applicant
VERTIS NEUROSCIENCE, INC.
2101 fourth avenue,suite 200
seattle, 
WA 
98121 -2329

Original Contact lori glastetter
Regulation Number 882.5890
Classification Product Code
NHI  
Subsequent Product Code
GXZ  
Date Received 07/11/2002
Decision Date 09/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No