510(k) K854573

ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE by Artec Environmental Monitoring Division — Product Code CAI

K854573 is an FDA 510(k) premarket notification submitted by Artec Environmental Monitoring Division for the device "ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE". The FDA issued a decision of Substantially Equivalent on January 3, 1986. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Artec Environmental Monitoring Division has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1986
Date Received
November 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device Class
Class I
Regulation Number
868.5240
Review Panel
AN
Submission Type