510(k) K955865

BEAR CUB INFANT PRESSURE VENTILATOR by Allied Healthcare Products, Inc. — Product Code CBK

K955865 is an FDA 510(k) premarket notification submitted by Allied Healthcare Products, Inc. for the device "BEAR CUB INFANT PRESSURE VENTILATOR". The FDA issued a decision of ST on August 6, 1996. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Allied Healthcare Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
August 6, 1996
Date Received
December 28, 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