510(k) K871366

SIEMENS MAIN FLOW BACTERIA FILTER by Siemens Elema AB — Product Code CAH

K871366 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "SIEMENS MAIN FLOW BACTERIA FILTER". The FDA issued a decision of Substantially Equivalent on May 14, 1987. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Siemens Elema AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1987
Date Received
April 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type