510(k) K952428

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

K952428 is an FDA 510(k) premarket notification submitted by Porous Media Corp. for the device "POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER". The FDA issued a decision of Substantially Equivalent on July 7, 1995. 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
July 7, 1995
Date Received
May 24, 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