510(k) K820577

ANESTHESIA BACTERIA FILTER by Omnicon Medical Corp. — Product Code CAH

K820577 is an FDA 510(k) premarket notification submitted by Omnicon Medical Corp. for the device "ANESTHESIA BACTERIA FILTER". The FDA issued a decision of Substantially Equivalent on Mar 18, 1982. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Omnicon Medical Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 18, 1982
Date Received
Mar 3, 1982
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