EBW NM 2.0


Device Classification Name

system, image processing, radiological

510(k) Number K111336
Device Name EBW NM 2.0
Applicant
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
3860 n. first street
san jose, 
CA 
95134

Applicant Contact lori r peterson
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/12/2011
Decision Date 05/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No