PHILIPS INTELLIVUE TCG10


Device Classification Name

monitor, carbon-dioxide, cutaneous

510(k) Number K110474
Device Name PHILIPS INTELLIVUE TCG10
Applicant
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
hewlett-packard str.2
boeblingen, 

DE

d 71034

Applicant Contact jens-peter seher
Correspondent
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
hewlett-packard str.2
boeblingen, 

DE

d 71034

Correspodent Contact jens-peter seher
Regulation Number 868.2480
Classification Product Code
LKD  
Subsequent Product Codes
KLK   LPP  
Date Received 02/18/2011
Decision Date 09/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls