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510(k) K043148

ALL FLOW PULMONARY FUNCTION FILTER by Alliance Tech Medical, Inc. — Product Code CAH

K043148 is an FDA 510(k) premarket notification submitted by Alliance Tech Medical, Inc. for the device "ALL FLOW PULMONARY FUNCTION FILTER". The FDA issued a decision of Substantially Equivalent on December 13, 2004. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2004
Date Received
November 15, 2004
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

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FDA data resources