MICROGARD II


Device Classification Name

filter, bacterial, breathing-circuit

510(k) Number K111408
Device Name MICROGARD II
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 868.5260
Classification Product Code
CAH  
Date Received 05/19/2011
Decision Date 10/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No