510(k) K951484

WESTMED BACTERIAL/VIRAL FILTER by Westmed Intl. — Product Code CAH

K951484 is an FDA 510(k) premarket notification submitted by Westmed Intl. for the device "WESTMED BACTERIAL/VIRAL FILTER". The FDA issued a decision of Substantially Equivalent on April 24, 1995. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Westmed Intl. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1995
Date Received
March 30, 1995
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