510(k) K812880

OHIO NON-REUSABLE TRACHEAL TUBE MAJILL by Airco/Ohio Medical Products — Product Code BTR

K812880 is an FDA 510(k) premarket notification submitted by Airco/Ohio Medical Products for the device "OHIO NON-REUSABLE TRACHEAL TUBE MAJILL". The FDA issued a decision of Substantially Equivalent on November 24, 1981. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Airco/Ohio Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1981
Date Received
October 14, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type