510(k) K984379

NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM by Puritan Bennett Corp. — Product Code CBK

K984379 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 10, 1998. 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
SESE (Substantially Equivalent)
Decision Date
December 10, 1998
Date Received
December 7, 1998
Clearance Type
Special
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