510(k) K954490

MERCURY MEDICAL CPR BAG EXHALATION FILTER by Mercury Medical — Product Code CAH

K954490 is an FDA 510(k) premarket notification submitted by Mercury Medical for the device "MERCURY MEDICAL CPR BAG EXHALATION FILTER". The FDA issued a decision of Substantially Equivalent on Oct 3, 1996. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Mercury Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 3, 1996
Date Received
Sep 27, 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