PNS MAGNETIC STIMULATOR SYSTEM


information about

Device Classification Name

stimulator, nerve, peripheral, electric

510(k) Number K002889
Device Name PNS MAGNETIC STIMULATOR SYSTEM
Original Applicant
NEOTONUS, INC.
49 plain st.
north attleboro, 
MA 
02760

Original Contact sheila hemeon-heyer
Regulation Number 868.2775
Classification Product Code
KOI  
Subsequent Product Code
GWF  
Date Received 09/15/2000
Decision Date 04/06/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No