SENTRYSUITE PRODUCT LINE


Device Classification Name

calculator, predicted values, pulmonary function

510(k) Number K111053
Device Name SENTRYSUITE PRODUCT LINE
Applicant
CAREFUSION GERMANY 234 GMBH
leibnizstrasse 7
hoechberg, bavaria, 

DE

97204

Applicant Contact elmar niedermeyer
Correspondent
CAREFUSION GERMANY 234 GMBH
leibnizstrasse 7
hoechberg, bavaria, 

DE

97204

Correspodent Contact elmar niedermeyer
Regulation Number 868.1890
Classification Product Code
BTY  
Subsequent Product Codes
BZC   BZG  
Date Received 04/15/2011
Decision Date 08/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No