ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80

Device Classification Name

stimulator, muscle, powered

510(k) Number K032954
Device Name ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80
Applicant
DANMETER A/S
kildemosevej 13
odense c, 

DK

dk-5000

Applicant Contact hanne nielsen
Correspondent
DANMETER A/S
kildemosevej 13
odense c, 

DK

dk-5000

Correspodent Contact hanne nielsen
Regulation Number 890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received 09/22/2003
Decision Date 08/09/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No