510(k) K965020

POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER by Porous Media Corp. — Product Code CAH

K965020 is an FDA 510(k) premarket notification submitted by Porous Media Corp. for the device "POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER". The FDA issued a decision of Substantially Equivalent on March 14, 1997. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Porous Media Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1997
Date Received
December 16, 1996
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