510(k) K896152
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