510(k) K901816

PRESSURE TUBING AND ACCESSORIES by Arbo Medical, Inc. — Product Code CAH

K901816 is an FDA 510(k) premarket notification submitted by Arbo Medical, Inc. for the device "PRESSURE TUBING AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on July 12, 1990. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Arbo Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1990
Date Received
April 23, 1990
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