GEMINI CONDOR


Device Classification Name

system, tomography, computed, emission

510(k) Number K081135
Device Name GEMINI CONDOR
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner rd.
cleveland, 
OH 
44143

Applicant Contact melinda novatny
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 04/21/2008
Decision Date 04/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls