DYNAWELL OR DYNAWELL


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K992120
Device Name DYNAWELL OR DYNAWELL
Applicant
EKEROTH QUALITY AB
nybrokajen 7
stockholm, 

SE

102 41

Applicant Contact nils ekeroth
Correspondent
EKEROTH QUALITY AB
nybrokajen 7
stockholm, 

SE

102 41

Correspodent Contact nils ekeroth
Regulation Number 892.1000
Classification Product Code
LNH  
Subsequent Product Code
JAK  
Date Received 06/23/1999
Decision Date 08/13/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No