510(k) K983817

BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F) by King Systems Corp. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1999
Date Received
October 29, 1998
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