510(k) K964540

NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM by Puritan Bennett Corp. — Product Code CBK

K964540 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM". The FDA issued a decision of ST on November 14, 1997. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
November 14, 1997
Date Received
November 12, 1996
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