510(k) K950484

TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR by Bird Products Corp. — Product Code CBK

K950484 is an FDA 510(k) premarket notification submitted by Bird Products Corp. for the device "TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR". The FDA issued a decision of ST on May 3, 1996. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Bird Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
May 3, 1996
Date Received
February 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type