510(k) K900428

ANESTHESIA BREATHING CIRCUITS by Med-Tek Corp. — Product Code CAI

K900428 is an FDA 510(k) premarket notification submitted by Med-Tek Corp. for the device "ANESTHESIA BREATHING CIRCUITS". The FDA issued a decision of Substantially Equivalent on August 17, 1990. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Med-Tek Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1990
Date Received
January 30, 1990
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