510(k) K896152

PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW. by Puritan Bennett Corp. — Product Code CAN

K896152 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.". The FDA issued a decision of Substantially Equivalent on January 9, 1990. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1990
Date Received
October 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Pressure, Gas Cylinder
Device Class
Class I
Regulation Number
868.2700
Review Panel
AN
Submission Type