510(k) K892520

BREATHING CIRCUIT BACTERIAL FILTERS by Arbo Medical, Inc. — Product Code CAH

K892520 is an FDA 510(k) premarket notification submitted by Arbo Medical, Inc. for the device "BREATHING CIRCUIT BACTERIAL FILTERS". The FDA issued a decision of Substantially Equivalent on August 2, 1989. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Arbo Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1989
Date Received
April 11, 1989
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