DEXACARE G4


Device Classification Name

densitometer, bone

510(k) Number K021331
Device Name DEXACARE G4
Original Applicant
OSTEOMETER MEDITECH, INC.
12515 chadron ave.
hawthorne, 
CA 
90250

Original Contact raja krishnamurti
Regulation Number 892.1170
Classification Product Code
KGI  
Date Received 04/26/2002
Decision Date 05/21/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No