510(k) K920783
K920783 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "OXYGEN FLOW CONTROLLER". The FDA issued a decision of Substantially Equivalent on September 18, 1992. The device falls under product code CCN (Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge), a Class I device regulated under 21 CFR 868.2300. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 1992
- Date Received
- February 20, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
- Device Class
- Class I
- Regulation Number
- 868.2300
- Review Panel
- AN
- Submission Type