510(k) K770286

VENTILATOR BREATHING CIRCUIT by Mcgaw Respiratory Therapy — Product Code CAI

K770286 is an FDA 510(k) premarket notification submitted by Mcgaw Respiratory Therapy for the device "VENTILATOR BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on February 25, 1977. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Mcgaw Respiratory Therapy has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1977
Date Received
February 14, 1977
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